Open, ClassifiedPosted Jun 10, 2025·Initiated May 22, 2025
Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.
Reason: Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
Root cause: Under Investigation by firm
Recalling firm: Stryker GmbHType: Rod, Fixation, Intramedullary And AccessoriesDistribution: Worldwide - US Nationwide distribution in the states of California and Missouri. The countries of Belgium, Japan, Netherlands.Recall #Z-1940-2025
Open, ClassifiedPosted Jun 9, 2025·Initiated Mar 21, 2025
OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
Reason: OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
Root cause: Process control
Recalling firm: GE Medical Systems, LLCType: Image-Intensified Fluoroscopic X-Ray System, MobileDistribution: US and OUSRecall #Z-1819-2025
Open, ClassifiedPosted Jun 9, 2025·Initiated Mar 21, 2025
OEC 3D
Reason: OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
Root cause: Process control
Recalling firm: GE Medical Systems, LLCType: Image-Intensified Fluoroscopic X-Ray System, MobileDistribution: US and OUSRecall #Z-1820-2025
Open, ClassifiedPosted Jun 9, 2025·Initiated May 21, 2025
Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU.
Newport HT70Plus Ventilator, REF: HT70PM-ES-EU, HT70PM-ES-NA, HT70PM-JP-NA, HT70PM-PT-BR, HT70PM-SY-AS, DLHT70PM-WW-NA, HT70PM-SY-NA, HT70PM-SY-UK, HT70PM-WW-EU, HT70PM-WW-UK, HT70PM-SY-EU, HT70PM-WWNA.
HT70-2 CONTROL BOARD ROHS X1, REF: GR105796.
HT70P CONTROL BOARD ROHS X1, REF: GR105795.
HT70 Conversion Kit, REF: GRFSKHT70M-2.
Reason: Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or the shutdown alert alarm fails to alarm effectively during shut down, which may result in respiratory failure, hypoventilation, low oxygen saturation, hypoxia, treatment delay.
Root cause: Component design/selection
Recalling firm: CovidienType: Ventilator, Continuous, Facility UseDistribution: Worldwide - US Nationwide distribution including in the states of MA, CT, KS, OH, PR, NH, GA, WI, MS, VA, CO, TX, MN, AL, IA, NY, UT, NM, KY, RI, SD, PA, IA, CA, MO, HI, MI, IL, MT, NJ, TN, SC, FL, IN, AZ, ID, LA, WA, NC, MD, WY, NE, NV, ND, ME, AK, DE, OK, OR and the countries of Japan, Canada, Singapore, Lithuania, Kazakhstan, Slovenia, Colombia, China, Qatar, United Arab Emirates, Greece, Saudi Arabia, Nigeria, Romania, Netherlands, Lebanon, Oman, Jordan, Malawi, India, Croatia, Portugal, Turkey, Brazil, Pakistan, Trinidad and Tobago, Slovakia, Chile, Egypt, Switzerland, South Africa, Thailand, Bangladesh, Myanmar, Peru, Uruguay, Hungary, Argentina, Iran, Islamic Republic Of, Costa Rica, Vietnam, Australia, Guatemala, Mexico, Guyana, Jamaica, Dominican Republic, Bahamas, Bosnia and Herzegovina, South Korea, Tunisia, Ukraine, Uzbekistan, Indonesia, Burkina Faso, Italy, Panama, Sri Lanka, Malaysia, Namibia, Swaziland, Spain, Philippines, Bhutan, Mauritius, Poland, France, Cambodia, Czechia, Israel, Norway, Russian Federation, United Kingdom, Canary Islands, Kenya, Czech Republic, Croatia , Estonia, Maldova, Palestine.Recall #Z-1915-2025 Open, ClassifiedPosted Jun 9, 2025·Initiated May 7, 2025
Brand Name: OBM00002 OBM DAB (Digital Acquisition Box)
Product Name: OBM00002 OBM DAB (Digital Acquisition Box)
Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box)
Software Version: N/A
Product Description: OBM00002 OBM DAB (Digital Acquisition Box)
Component: No
Reason: Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this device.
Root cause: Employee error
Recalling firm: Natus Neurology DBA Excel Tech., Ltd. (XLTEK)Type: Amplitude-Integrated ElectroencephalographDistribution: Worldwide distribution - US Nationwide including Puerto Rico (PR) and OUS (foreign) countries of: Italy (IT), Estonia (EE), Israel (IL), China (CN), Germany (DE), Saudi Arabia (SA), Switzerland (CH), Chile (CL), Colombia (CO), Netherlands (the) (NL), Japan (JP), United Kingdom of Great Britain and Northern Ireland(the) (GB), Russian Federation (the)(RU), Bolivia (Plurinational State of) (BO), Canada (CA), France (FR), Peru (PE), Guyana (GY), Mexico (MX), Belgium (BE), Thailand (TH), Paraguay (PY), Hong Kong (HK), United Arab Emirates (AE), Austria (AT), India (IN), Indonesia (ID), Kuwait (KW), Qatar (QA), Lithuania (LT), Denmark (DK), Myanmar (MM), Uruguay (UY), Tunisia (TN), Turkey (TR), Korea (the Republic of) (KR), Hungary (HU), Slovenia (SI), Argentina (AR), Norway (NO), Oman (OM), Poland (PL), Finland (FI), Ireland (IE), Australia (AU), Latvia (LV), Ecuador (EC), Singapore (SG), Spain (ES), Serbia (RS), South Africa (ZA), Romania (RO), Algeria (DZ), Portugal (PT), Dominican Republic (the) (DO), Lebanon (LB), Malaysia (MY), Costa Rica (CR), Viet Nam (VN), & Bahrain (BH).Recall #Z-1925-2025
Open, ClassifiedPosted Jun 9, 2025·Initiated May 23, 2025
EPIONE Model 30-0001
UDI-DI code: 03760305400031
The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous ablation
procedures in the abdomen, performed by physicians trained for CT procedures and performed under general anaesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G.
Reason: Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
Root cause: Under Investigation by firm
Recalling firm: QUANTUM SURGICAL SASType: System, X-Ray, Tomography, ComputedDistribution: Worldwide distribution - U.S. Nationwide distribution in the states of FL,IL, IN, and TX. The countries of France, Germany and United Kingdom.Recall #Z-1927-2025
Open, ClassifiedPosted Jun 9, 2025·Initiated May 29, 2025
Achieva XR
Product Numbers: (1) 781153, (2) 781253;
Reason: identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Root cause: Process design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, DE, MA, MI, MY, NE, NY, SD and the countries of Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, Spain.Recall #Z-1928-2025
Open, ClassifiedPosted Jun 9, 2025·Initiated May 29, 2025
Intera 1.5T Achieva IT Nova
Product Number: 781175
Reason: identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Root cause: Process design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, DE, MA, MI, MY, NE, NY, SD and the countries of Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, Spain.Recall #Z-1929-2025
Open, ClassifiedPosted Jun 9, 2025·Initiated May 29, 2025
Intera 1.5T Achieva Nova
Product Number: 781172;
Reason: identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Root cause: Process design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, DE, MA, MI, MY, NE, NY, SD and the countries of Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, Spain.Recall #Z-1930-2025
Open, ClassifiedPosted Jun 9, 2025·Initiated May 29, 2025
Intera 1.5T Achieva Nova-Dual
Product Number: 781173;
Reason: identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Root cause: Process design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, DE, MA, MI, MY, NE, NY, SD and the countries of Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, Spain.Recall #Z-1931-2025
Open, ClassifiedPosted Jun 9, 2025·Initiated May 29, 2025
Intera 1.5T Explorer/Nova Dual
Product Number: 781108;
Reason: identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Root cause: Process design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, DE, MA, MI, MY, NE, NY, SD and the countries of Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, Spain.Recall #Z-1932-2025
Open, ClassifiedPosted Jun 9, 2025·Initiated May 29, 2025
Intera 1.5T Master/Nova
Product Number: 781106;
Reason: identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Root cause: Process design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, DE, MA, MI, MY, NE, NY, SD and the countries of Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, Spain.Recall #Z-1933-2025
Open, ClassifiedPosted Jun 9, 2025·Initiated May 29, 2025
Intera 1.5T Omni/Stellar;
Product Number: 781104;
Reason: identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Root cause: Process design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, DE, MA, MI, MY, NE, NY, SD and the countries of Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, Spain.Recall #Z-1934-2025
Open, ClassifiedPosted Jun 9, 2025·Initiated May 29, 2025
Intera Achieva 1.5T Pulsar;
Product Number: 781171;
Reason: identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Root cause: Process design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, DE, MA, MI, MY, NE, NY, SD and the countries of Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, Spain.Recall #Z-1935-2025
Open, ClassifiedPosted Jun 9, 2025·Initiated May 29, 2025
SmartPath to dStream for 1.5T;
Product Number: 782146;
Reason: identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Root cause: Process design
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, DE, MA, MI, MY, NE, NY, SD and the countries of Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, Spain.Recall #Z-1936-2025
Open, ClassifiedPosted Jun 9, 2025·Initiated May 2, 2025
BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
Reason: Swabs for specimen collection may be prone to breakage during product usage.
Root cause: Nonconforming Material/Component
Recalling firm: Copan ItaliaType: System, Transport, AerobicDistribution: US Nationwide distribution in the state of MD.Recall #Z-1937-2025
Open, ClassifiedPosted Jun 6, 2025·Initiated May 7, 2025
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Reason: Unreleased software versions were installed on distributed devices without verification or validation.
Root cause: Software design (manufacturing process)
Recalling firm: Zyno Medical LLCType: Pump, InfusionDistribution: US NationwideRecall #Z-1865-2025
Open, ClassifiedPosted Jun 6, 2025·Initiated May 7, 2025
Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Reason: Unreleased software versions were installed on distributed devices without verification or validation.
Root cause: Software design (manufacturing process)
Recalling firm: Zyno Medical LLCType: Pump, InfusionDistribution: US NationwideRecall #Z-1866-2025
Open, ClassifiedPosted Jun 6, 2025·Initiated May 7, 2025
Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Reason: Unreleased software versions were installed on distributed devices without verification or validation.
Root cause: Software design (manufacturing process)
Recalling firm: Zyno Medical LLCType: Pump, InfusionDistribution: US NationwideRecall #Z-1867-2025
Open, ClassifiedPosted Jun 6, 2025·Initiated May 7, 2025
Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Reason: Unreleased software versions were installed on distributed devices without verification or validation.
Root cause: Software design (manufacturing process)
Recalling firm: Zyno Medical LLCType: Pump, InfusionDistribution: US NationwideRecall #Z-1868-2025