Open, ClassifiedPosted May 16, 2025·Initiated Apr 17, 2025
Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
Reason: Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Root cause: Under Investigation by firm
Recalling firm: Cook IncorporatedType: Introducer, CatheterDistribution: Worldwide distribution - US Nationwide and the countries of Belgium, Germany, Spain, France, Ireland, Italy Netherlands, Switzerland, South Africa, Slovenia.Recall #Z-1787-2025
Open, ClassifiedPosted May 16, 2025·Initiated May 13, 2025
Product Name: SmartPath to dStream for 1.5T;
Model Numbers: (1) 781260, (2) 782112, (3) 782146
Reason: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Root cause: Software design
Recalling firm: Philips North America LlcType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.Recall #Z-1788-2025 Open, ClassifiedPosted May 16, 2025·Initiated May 13, 2025
Product Name: SmartPath to dStream for 3.0T;
Model Number: 782145
Reason: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Root cause: Software design
Recalling firm: Philips North America LlcType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.Recall #Z-1789-2025 Open, ClassifiedPosted May 16, 2025·Initiated May 13, 2025
Product Name: SmartPath to dStream for XR and 3.0T;
Model Numbers: (1) 781270, (2) 782113;
Reason: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Root cause: Software design
Recalling firm: Philips North America LlcType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.Recall #Z-1790-2025 Open, ClassifiedPosted May 16, 2025·Initiated May 13, 2025
Product Name: SmartPath to Ingenia Elition X;
Model Numbers: (1) 782118, (2) 782144;
Reason: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Root cause: Software design
Recalling firm: Philips North America LlcType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.Recall #Z-1791-2025 Open, ClassifiedPosted May 16, 2025·Initiated May 13, 2025
Product Name: Upgrade to MR 7700;
Model Number: 782130;
Reason: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Root cause: Software design
Recalling firm: Philips North America LlcType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.Recall #Z-1792-2025 Open, ClassifiedPosted May 16, 2025·Initiated May 13, 2025
Product Name: Evolution Upgrade 1.5T;
Model Numbers: (1) 782116, (2) 782148;
Reason: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Root cause: Software design
Recalling firm: Philips North America LlcType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.Recall #Z-1793-2025 Open, ClassifiedPosted May 16, 2025·Initiated May 13, 2025
Product Name: Evolution Upgrade 3.0T;
Model Numbers: (1) 782117, (2) 782143;
Reason: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Root cause: Software design
Recalling firm: Philips North America LlcType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.Recall #Z-1794-2025 Open, ClassifiedPosted May 16, 2025·Initiated May 13, 2025
Product Name: Ingenia 1.5T;
Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
Reason: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Root cause: Software design
Recalling firm: Philips North America LlcType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.Recall #Z-1795-2025 Open, ClassifiedPosted May 16, 2025·Initiated May 13, 2025
Product Name: Ingenia 1.5T S;
Model Number: 781347;
Reason: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Root cause: Software design
Recalling firm: Philips North America LlcType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.Recall #Z-1796-2025 Open, ClassifiedPosted May 16, 2025·Initiated May 13, 2025
Product Name: Ingenia 3.0T;
Model Numbers: (1) 781342, (2) 781377, (3) 782103;
Reason: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Root cause: Software design
Recalling firm: Philips North America LlcType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.Recall #Z-1797-2025 Open, ClassifiedPosted May 16, 2025·Initiated May 13, 2025
Product Name: Ingenia Ambition S;
Model Numbers: (1) 781359, (2) 782108, (3) 782139;
Reason: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Root cause: Software design
Recalling firm: Philips North America LlcType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.Recall #Z-1798-2025 Open, ClassifiedPosted May 16, 2025·Initiated May 13, 2025
Product Name: Ingenia 1.5T CX;
Model Number: 781262;
Reason: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Root cause: Software design
Recalling firm: Philips North America LlcType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.Recall #Z-1799-2025 Open, ClassifiedPosted May 16, 2025·Initiated May 13, 2025
Product Name: Ingenia 3.0T CX;
Model Number: 781271;
Reason: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Root cause: Software design
Recalling firm: Philips North America LlcType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.Recall #Z-1800-2025 Open, ClassifiedPosted May 16, 2025·Initiated May 13, 2025
Product Name: Ingenia Ambition X;
Model Numbers: (1) 781356, (2) 782109, (3) 782138;
Reason: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Root cause: Software design
Recalling firm: Philips North America LlcType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.Recall #Z-1801-2025 Open, ClassifiedPosted May 16, 2025·Initiated May 13, 2025
Product Name: Ingenia Elition S;
Model Numbers: (1) 781357, (2) 782106, (3) 782137;
Reason: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Root cause: Software design
Recalling firm: Philips North America LlcType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.Recall #Z-1802-2025 Open, ClassifiedPosted May 16, 2025·Initiated May 13, 2025
Product Name: Ingenia Elition X;
Model Numbers: (1) 781358, (2) 782107, (3) 782136;
Reason: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Root cause: Software design
Recalling firm: Philips North America LlcType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.Recall #Z-1803-2025 Open, ClassifiedPosted May 16, 2025·Initiated May 13, 2025
Product Name: MR 5300;
Model Numbers: (1) 782110, (2) 782152;
Reason: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Root cause: Software design
Recalling firm: Philips North America LlcType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.Recall #Z-1804-2025 Open, ClassifiedPosted May 16, 2025·Initiated May 13, 2025
Product Name: MR 7700;
Model Numbers: (1) 782120, (2) 782153;
Reason: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Root cause: Software design
Recalling firm: Philips North America LlcType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.Recall #Z-1805-2025 Open, ClassifiedPosted May 15, 2025·Initiated Apr 9, 2025
Centurion Sterile Weitlaner Retractor, Reorder: 67315
Reason: Three is the potential for the retractors to puncture through the sterile packaging.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: RetractorDistribution: US Nationwide distribution.Recall #Z-1765-2025