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Mini Multi TEE Transducer Probe recallZ-2385-2025 · Philips Ultrasound, Inc · initiated Jul 3, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips Ultrasound, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

FDA root cause category: Device Design

What the company is doing

An URGENT Medical Device Correction Notice, dated 7/3/25, was mailed to consignees. This notice instructs consignees to locate all Philips Ultrasound transducers in their facility and enter their serial numbers into https://www.transducer.philips.com to obtain the manufacturing certificate for each of their devices. This certificate should be retained with its system documentation. Using the manufacturing certificate consignees are to calculate the useful life of their device. The expected useful life for Transesophageal transducers, X-Matrix transducers, and Lumify transducers is 5 years; The expected useful life for Endocavity transducers and Transcutaneous transducers is 7 years. If a transducer has exceeded its useful life, consignees are instructed to conduct transducer performance tests or contact Philips for guidance. Consignees are asked to complete and return the provided response form and circulate the recall notification to device users for their awareness. Consignees with any questions can contact Philips Customer Care Solutions Center at 1-800-722-9377.

Recall details

Recall number
Z-2385-2025
Status
Open, Classified
Initiated by the company
Jul 3, 2025
Posted by the FDA
Aug 22, 2025
Recalling firm
Philips Ultrasound, Inc
Quantity
171,322 units
Product code
IYN
FDA submissions
K043535, K132304, K160807, K163120, K172607
Distribution
US Nationwide distribution.

Product description

Mini Multi TEE Transducer Probe

Code information (models, lots, serial numbers)

Model No. 989605439242, 21381A; UDI: (01)00884838067547(21)B0DTV4, (01)00884838067547(21)B01639, (01)00884838067547(21)B06NT3; Serial No. 0341YT, 0319CQ, 028NZW, B0RF1J, B0F31L, B0DTV4, B0C9XR, 02H0L8, B0KYGV, B01639, B06NT3, 03C68B, 03C8CW.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 97217).

Sources and updates

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