September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls L12-4 Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls L12-3 Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls L11-3 Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls L10-4LAP Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls eL18-4 Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls D5cwc Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls D2TCD Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls D2cwc Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls C9-5ec Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls C9-4v Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls C9-4 Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls C9-3v Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls C9-3io Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls C9-2 Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls C8-5 Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls C8-4v Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls C8-4v Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls C6-3 Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls C6-2 Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls C5-2 Lumify Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls C5-2 Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls c5-1 Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls C10-4ec Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls C10-3v Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls BP10-5ec Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls 7.5MHZ Endo Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls 3D9-3v Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls 3D6-2 Transducer Probe
Hazard: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
September 3, 2025Medical DevicesFDA
Tandem Diabetes Care, Inc. recalls Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacemen
Hazard: Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in a hyperglycemic event, which may lead to injury and/or hospitalization.
September 3, 2025Medical DevicesFDA
GE Medical Systems, LLC recalls GE HealthCare OEC 9900 Elite C-arm Systems.
Hazard: 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.