Philips Ultrasound recalled 11 Mini Multi TEE ultrasound transducers distributed nationwide in the United States after a labeling clarification related to useful life. The recall centers on providing clarification and labeling to define the useful life of transducers in the field. Healthcare providers should stop using the device and follow recall instructions from Philips Ultrasound, Inc or their
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.
The Mini Multi TEE Ultrasound Transducer is a specialized probe used in transesophageal echocardiography. It is deployed by clinicians during cardiac imaging procedures.
The recall targets labeling intended to define the transducer’s useful life. The issue may lead to misuse if life expectancy is not clearly defined in the labeling.
This recall is not described as part of a broader industry pattern.
Hospitals and clinics with the recalled units must verify identifiers and may need to halt use per recall instructions. The recall involves 11 units across the U.S., which could disrupt certain cardiac imaging workflows.
FDA enforcement recall page at the provided link and Philips Ultrasound customer support site.
Remedy processing may take weeks. Philips will provide replacement or guidance after confirmation of identifiers.
Retain recall notice, quotes of any communications, model numbers, serials, and dates of contact with Philips or healthcare providers.
Brand: Philips Ultrasound Product: Mini Multi TEE Ultrasound Transducer Models/Identifiers: 989605439241, 989605439242, 21381A, UDI: (01)00884838067547(21)B093BQ, (01)00884838067547(21)B0988T, (01)00884838067547(21)02P6MY, (01)00884838067547(21)039M2Q, (01)00884838067547(21)0319CQ, (01)00884838067547(21)B01639, Serial No.: 02GXR0, Additional SNs/UDIs: B093BQ, B0988T, 02P6MY, 039M2Q, 0341YT, 0319CQ, 028NZW, 02H0L8, B01639, 039M2M. Quantity recalled: 11 units Sold/distribution: US Nationwide distribution Recall date: 2025-09-05 Status: ACTIVE
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 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.
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.
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 Ultrasound recalled 1 unit of the C9-4 Ultrasound Transducer, Model No. 989605365021, distributed nationwide in the United States. The recall focuses on clarifying and labeling the device’s useful life. Healthcare providers and patients should stop using the device immediately and follow Philips’ instructions for replacement or further steps.
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.