Philips recalled 40 L12-5 ultrasound transducers distributed nationwide in the United States after regulators flagged labeling to define the devices' useful life. The recall concerns labeling clarity rather than a device malfunction. Healthcare providers and patients should stop using the device immediately and await instructions from Philips Ultrasound, Inc or their healthcare provider.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips Ultrasound, Inc or your healthcare provider for instructions. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Ultrasound transducers are handheld devices used with ultrasound systems to capture diagnostic images. The L12-5 is a specified model in Philips’ range used in medical imaging.
The recall focuses on clarifying the labeling related to the device's useful life rather than an acute malfunction. The labeling clarification is intended to prevent improper servicing or use past defined life.
This recall is not described as part of a broader industry pattern in the notice.
No injuries reported. Immediate action required to prevent potential misinterpretation of device life and servicing timelines.
Refer to the FDA enforcement page linked in the recall notice and Philips recall communications.
Recall instructions will be provided by Philips. No explicit replacement timeline is given in the notice.
Save the recall letter, note model/serial numbers, and all correspondence with Philips or providers.
Quantity: 40 units. Distribution: US Nationwide. Models include 989605412401, 989605387311, 989605418552, 989605408173, 989605438481, 989605420231. UDI entries and serial numbers listed: UDI (01)00884838067851(21)B27H7T; (01)00884838067974(21)B0B0B1; (01)00884838067851(21)B16RRG; (01)00884838067974(21)B0HWBM; (01)00884838067974(21)B0B39M; (01)00884838067851(21)B1N2FG; (01)00884838067851(21)B1DD6B; (01)00884838067851(21)B27GVB; (01)00884838067851(21)B27RQ7; (01)00884838067851(21)B1WT18; (01)00884838067851(21)B1N1JB. Serial Nos. B107H4, B106RJ, B02RKJ.
No injuries or incidents have been reported.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
Philips Ultrasound recalled 4,819 diagnostic ultrasound systems on October 31, 2025. The recall affects models 795005, 795161, and 989605449841 due to compatibility issues with Apple devices running iOS 18. These issues may prevent the systems from performing live imaging, posing risks in medical settings.
Philips Ultrasound recalled 2 units of the Philips OMNI II TEE Ultrasound Transducer sold nationwide through multiple retailers. The recall seeks labeling clarification to define the transducer's useful life. Healthcare facilities should stop using the devices and follow Philips recall instructions.
Philips Ultrasound recalled 75 OMNI III TEE Ultrasound Transducers distributed nationwide in the United States. The recall concerns labeling to define the useful life of these transducers in the field. Healthcare facilities should stop using the devices immediately and follow the recall instructions from Philips Ultrasound, Inc.
Philips Ultrasound recalled 1 unit of the S5-2 Ultrasound Transducer sold nationwide through healthcare distributors. The recall clarifies labeling to define the useful life of the transducer in the field. Healthcare providers should stop using the device and contact Philips Ultrasound for instructions.
Two Philips Ultrasound L17-5 transducers distributed nationwide to hospitals are recalled. The recall targets labeling that defines the devices' useful life. Stop using the transducers and follow Philips Ultrasound's instructions. Hospitals should contact Philips Ultrasound for guidance.
Philips Ultrasound, Inc. recalled 41 S4-1 Ultrasound Transducers distributed nationwide in the United States. The recall is to provide clarification and labeling to define the useful life of ultrasound transducers in the field. Healthcare providers should stop using these devices immediately and follow the recall instructions from Philips or their facility.
Philips recalled 17 units of the 3D6-2 Ultrasound Transducer distributed nationwide to healthcare facilities in the United States. The recall seeks to clarify labeling defining the transducer’s useful life. Clinicians and facilities should stop using the device immediately and follow Philips recall instructions.
Philips Ultrasound recalled 5 X7-2 ultrasound transducers distributed nationwide to healthcare providers. The recall is to provide clarification and labeling to define the useful life of ultrasound transducers in the field. Healthcare facilities should stop using the recalled devices and follow Philips Ultrasound, Inc instructions or contact their provider for guidance.