FDA Medical Device Recalls (openFDA)
Philips Ultrasound, Inc: Philips X7-2 Ultrasound Transducer
- Recall number
- Z-1628-2026
- Recalling firm
- Philips Ultrasound, Inc
- Product
- Philips X7-2 Ultrasound Transducer
- Status
- Open, Classified
- Initiated
- 2025-09-05
- Posted
- 2026-03-24
- Terminated
- not on file
- Reason
- To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Root cause
- Device Design
- Action
- An URGENT Medical Device Correction Notice, dated 8/19/25, 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.
- Quantity
- 5 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Model No. 989605388121, 989605347571, 989605347573; UDI: (01)00884838061729(21)0344RZ; Serial No. 03FG1T, 031LM2, 032Q7G, 0344RZ, 033VM9.
- 510(k) numbers
- ["K160807","K163120","K172607","K181485","K182857"]
- PMA numbers
- not on file
- Product code
- ITX
- Firm FEI
- 2518586
- Firm city
- Reedsville
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28