Open, ClassifiedPosted Aug 25, 2025·Initiated Jul 11, 2025
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
Reason: Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Root cause: Under Investigation by firm
Recalling firm: Onkos Surgical, Inc.Type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedDistribution: US Nationwide distribution in the states of AK, AZ, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, TN, TX, UT, WA & WI.Recall #Z-2425-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 2, 2025
GE HealthCare OEC 9800.
Reason: GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: GE Medical Systems, LLCType: Interventional Fluoroscopic X-Ray SystemDistribution: US Nationwide distribution.Recall #Z-2341-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 2, 2025
GE HealthCare OEC 9900 Elite C-arm Systems.
Reason: GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: GE Medical Systems, LLCType: Interventional Fluoroscopic X-Ray SystemDistribution: US Nationwide distribution.Recall #Z-2342-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 16, 2025
Dynex Agility Sample Tips;
Model Number: 67910;
The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.
Reason: The internal label affixed to the sample tip rack is incorrectly labeled as reagent tip racks. When scanned by the Agility instrument, the tip rack is misidentified as a different tip type, rendering it incompatible with the system and preventing use which causes a delay in obtaining patient results.
Root cause: Labeling Change Control
Recalling firm: Dynex Technologies, Inc.Type: Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseDistribution: Domestic: CA, FL, NC, NJ, NY;Recall #Z-2345-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
3D6-2 Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2346-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
3D9-3v Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2347-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
7.5MHZ Endo Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: Transducer, Ultrasonic, DiagnosticDistribution: US Nationwide distribution.Recall #Z-2348-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
BP10-5ec Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2349-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
C10-3v Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2350-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
C10-4ec Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2351-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
c5-1 Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2352-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
C5-2 Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2353-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
C5-2 Lumify Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2354-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
C6-2 Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2355-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
C6-3 Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2356-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
C8-4v Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2357-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
C8-4v Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2358-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
C8-5 Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2359-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
C9-2 Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2360-2025
Open, ClassifiedPosted Aug 22, 2025·Initiated Jul 3, 2025
C9-3io Transducer Probe
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause: Device Design
Recalling firm: Philips Ultrasound, IncType: System, Imaging, Pulsed Doppler, UltrasonicDistribution: US Nationwide distribution.Recall #Z-2361-2025