Open, ClassifiedPosted Apr 27, 2026·Initiated Apr 14, 2026
Philips Ingenia Ambition X with MR Elastography (MRE).
1. Model Number (REF): 781356.
2. Model Number (REF): 782109.
3. Model Number (REF): 782138.
4. Model Number (REF): 782160.
Reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Root cause: Under Investigation by firm
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.Recall #Z-1961-2026
Open, ClassifiedPosted Apr 27, 2026·Initiated Apr 14, 2026
Philips Ingenia Elition S with MR Elastography (MRE).
1. Model Number (REF): 781357.
2. Model Number (REF): 782106.
3. Model Number (REF): 782137.
Reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Root cause: Under Investigation by firm
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.Recall #Z-1962-2026
Open, ClassifiedPosted Apr 27, 2026·Initiated Apr 14, 2026
Philips Ingenia Elition X with MR Elastography (MRE).
1. Model Number (REF): 781358.
2. Model Number (REF): 782107.
3. Model Number (REF): 782136.
510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808
Reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Root cause: Under Investigation by firm
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.Recall #Z-1963-2026
Open, ClassifiedPosted Apr 27, 2026·Initiated Apr 14, 2026
Philips MR 7700 with MR Elastography (MRE).
1. Model Number (REF): 782120.
2. Model Number (REF): 782153.
Reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Root cause: Under Investigation by firm
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.Recall #Z-1964-2026
Open, ClassifiedPosted Apr 27, 2026·Initiated Apr 14, 2026
Philips SmartPath to dStream for 1.5T with MR Elastography (MRE).
1. Model Number (REF): 781260.
2. Model Number (REF): 782112.
Reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Root cause: Under Investigation by firm
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.Recall #Z-1965-2026
Open, ClassifiedPosted Apr 27, 2026·Initiated Apr 14, 2026
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE).
1. Model Number (REF): 782145.
Reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Root cause: Under Investigation by firm
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.Recall #Z-1966-2026
Open, ClassifiedPosted Apr 27, 2026·Initiated Apr 14, 2026
Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE).
1. Model Number (REF): 781270.
2. Model Number (REF): 782113.
Reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Root cause: Under Investigation by firm
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.Recall #Z-1967-2026
Open, ClassifiedPosted Apr 27, 2026·Initiated Apr 14, 2026
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE).
1. Model Number (REF): 782118.
2. Model Number (REF): 782144.
3. Model Number (REF): 782163.
Reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Root cause: Under Investigation by firm
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.Recall #Z-1968-2026
Open, ClassifiedPosted Apr 27, 2026·Initiated Apr 14, 2026
Philips Upgrade to MR 7700 with MR Elastography (MRE).
1. Model Number (REF): 782130.
Reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Root cause: Under Investigation by firm
Recalling firm: Philips North AmericaType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.Recall #Z-1969-2026
Open, ClassifiedPosted Apr 24, 2026·Initiated Mar 19, 2026
Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as:
1. ESSENTIO SR SL, Model Number L100;
2. ESSENTIO DR SL Pacemaker, Model Number L101;
3. ESSENTIO SR SL MRI Pacemaker, Model Number L110;
4. ESSENTIO DR SL MRI Pacemaker, Model Number L111;
5. ESSENTIO DR EL Pacemaker, Model Number L121;
6. ESSENTIO DR EL MRI Pacemaker, Model Number L131;
7. PROPONENT SR SL Pacemaker, Model Number L200;
8. PROPONENT DR SL Pacemaker, Model Number L201;
9. PROPONENT DR (VDD) SL Pacemaker, Model Number L209;
10. PROPONENT SR SL Pacemaker, Model Number L210;
11. PROPONENT DR SL MRI Pacemaker, Model Number L211;
12. PROPONENT DR EL Pacemaker, Model Number L221;
13. PROPONENT DR EL MRI Pacemaker, Model Number L231*;
14. ACCOLADE SR SL Pacemaker, Model Number L300;
15. ACCOLADE DR SL Pacemaker, Model Number L301;
16. ACCOLADE SR SL MRI Pacemaker, Model Number L310;
17. ACCOLADE DR SL MRI Pacemaker, Model Number L311;
18. ACCOLADE DR EL Pacemaker, Model Number L321;
19. ACCOLADE DR EL MRI Pacemaker, Model Number L331*;
20. ALTRUA 2 SR SL Pacemaker, Model Number S701;
21. ALTRUA 2 DR SL Pacemaker, Model Number S702;
22. ALTRUA 2 DR EL Pacemaker, Model Number S722.
Reason: Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices.
Dual chamber modes are specifically indicated for treatment of the following:
" Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block
" VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm
" Low cardiac output or congestive heart failure secondary to bradycardia
Root cause: Nonconforming Material/Component
Recalling firm: Boston Scientific CorporationType: Implantable Pulse Generator, Pacemaker (Non-Crt)Distribution: worldwideRecall #Z-1770-2026 Open, ClassifiedPosted Apr 24, 2026·Initiated Mar 19, 2026
Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as:
1. VALITUDE CRT-P EL, Model Number U125;
2. VALITUDE CRT-P EL MRI, Model Number U128;
3. VISIONIST CRT-P EL, Model Number U225;
4. VISIONIST CRT-P EL, Model Number U226;
5. VISIONIST CRT-P EL MRI, Model Number U228.
Reason: Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices.
Dual chamber modes are specifically indicated for treatment of the following:
" Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block
" VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm
" Low cardiac output or congestive heart failure secondary to bradycardia
Root cause: Nonconforming Material/Component
Recalling firm: Boston Scientific CorporationType: Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)Distribution: worldwideRecall #Z-1771-2026 Open, ClassifiedPosted Apr 24, 2026·Initiated Dec 29, 2025
WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.
Reason: Cyber vulnerability of BLE communication was found by CISA VDP program.
Root cause: Device Design
Recalling firm: WHILL, INC.Type: Wheelchair, PoweredDistribution: US: KansasRecall #Z-1826-2026
Open, ClassifiedPosted Apr 24, 2026·Initiated Dec 29, 2025
WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel
drive) powered wheelchair.
Reason: Cyber vulnerability of BLE communication was found by CISA VDP program.
Root cause: Device Design
Recalling firm: WHILL, INC.Type: Wheelchair, PoweredDistribution: US: KansasRecall #Z-1827-2026
Open, ClassifiedPosted Apr 24, 2026·Initiated Mar 12, 2026
Mesh Style Tip Protectors
CSW-03-2.0 Open-end style
CSW-04-4.0 Closed-end style
Reason: Product does not have FDA clearance.
Root cause: No Marketing Application
Recalling firm: Healthmark Industries Co., Inc.Type: Endoscopic Storage CoverDistribution: US Nationwide distribution.Recall #Z-1943-2026
Open, ClassifiedPosted Apr 24, 2026·Initiated Mar 9, 2026
VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
Reason: There is a possibility of reagent leakage from the specimen container.
Root cause: Under Investigation by firm
Recalling firm: Milestone S.R.L.Type: Container, Specimen, Non-SterileDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Chile, Israel, UK, Belgium, Spain, France, Greece, Italy, Luxembourg, The Netherlands, Portugal, and Sweden.Recall #Z-1944-2026
Open, ClassifiedPosted Apr 24, 2026·Initiated Mar 9, 2026
Brand Name: Kiwi Omni Vacuum Delivery System
Product Name: Kiwi Omni Vacuum Delivery System
Model/Catalog Number: VAC-6000MT
Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is
a sterile, single-patient-use device designed to provide assistance in childbirth under the
following conditions: 1) Term pregnancy, 2) Ruptured amniotic membranes, 3) Engaged head,
4) Complete cervical dilation, and 5) Adequately trained or supervised operator.
Reason: Due to complaints of device breakage at the traction force gauge to handle joint.
Root cause: Under Investigation by firm
Recalling firm: Clinical Innovations, LLCType: Extractor, Vacuum, FetalDistribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AR, AZ, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MI, MN, MS, NC, NE, NH, NV, NY, OH, PR, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Canada, China, Japan, Czech Republic, and Singapore.Recall #Z-1945-2026
Open, ClassifiedPosted Apr 24, 2026·Initiated Mar 30, 2026
Brand Name: Disposable Mixing Bowls with Spatula
Product Name: Mixing Bowl and Spatula
Model/Catalog Number: 00-5049-011-00
Software Version: N/A
Product Description: Mixing Bowl and Spatula
Component: N/A
Reason: Ten complaints have been received identifying issues at the time of use related to the package seal,
including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.
Root cause: Vendor change control
Recalling firm: Zimmer, Inc.Type: Mixer, Cement, For Clinical UseDistribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, MI, MO, MS, NC, NE, NM, NY, OH, OK, PA, SD, TN, TX, UT, WA, WI and the countries of Canada, Australia, New Zealand, Malaysia, EMEA, Chile.Recall #Z-1946-2026
Open, ClassifiedPosted Apr 24, 2026·Initiated Mar 11, 2026
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
Reason: Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implanted. The observation is caused by an interaction between the Sphere-9 catheter current flow and a safety feature built into Biotronik ICDs and CRT Ds. Medtronic recommends physicians use increased caution when using the Sphere-9 catheter for RF ablation therapy in patients implanted with a Biotronik ICD/CRT-D system, and to ensure external defibrillation systems are readily available.
Root cause: Device Design
Recalling firm: Medtronic, Inc.Type: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FlutterDistribution: WorldwideRecall #Z-1948-2026 Open, ClassifiedPosted Apr 24, 2026·Initiated Mar 23, 2026
Brand Name: Genius" Review Station
Product Name: Genius" Review Station Display (Barco Monitor)
Model/Catalog Number: CMP-01669
Software Version: N/A - not software version specific
Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics System with the Genius" Cervical AI Algorithm cleared under DEN210035.
Reason: It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling Barco Application Appearance Manager (AAM), altering calibration and compliance parameters, and adjusting additional display-related settings. This field correction is being conducted to restore affected system to the validated configuration and reinforce proper use in accordance with the Operator's Manual.
Root cause: Software design
Recalling firm: Hologic, IncType: Digital Cervical Cytology Slide Imaging System With Artificial Intelligence AlgorithmDistribution: Worldwide distribution - US Nationwide and the countries of Asia Pacific, Europe, and the Middle East.Recall #Z-1949-2026 Open, ClassifiedPosted Apr 23, 2026·Initiated Mar 24, 2026
Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995.
Reason: Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
Root cause: Software change control
Recalling firm: Foundation Medicine, Inc.Type: Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection SystemDistribution: US distribution to North Carolina and Massachusetts.Recall #Z-1937-2026