Transducer S4-1 recallZ-1625-2026 · Philips Ultrasound, Inc · initiated Sep 5, 2025
Open, Classified
Is my device affected?
- 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.
- 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.
- 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 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.
Recall details
- Recall number
- Z-1625-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 5, 2025
- Posted by the FDA
- Mar 24, 2026
- Recalling firm
- Philips Ultrasound, Inc
- Quantity
- 41 units
- Product code
- ITX
- FDA submissions
- K120321, K153480, K162549, K192226, K030455
- Distribution
- US Nationwide distribution.
Product description
Philips S4-1 Ultrasound Transducer
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
Model No. 989605458221, 989605458222, 989605477101; UDI: (01)00884838085183(21)B25VV3, (01)00884838085183(21)B21XVK, (01)00884838085183(21)B1ZJVG, (01)00884838085183(21)B2D31R, (01)00884838085183(21)B21XXK, (01)00884838085183(21)B25VX0, (01)00884838085183(21)B21Y07, (01)00884838085183(21)B21Y6L, (01)00884838085183(21)B21XYW, (01)00884838085183(21)B1RCNL, (01)00884838074231(21)B21Y64, (01)00884838074231(21)B21YF6, (01)00884838085183(21)B2D34Z, (01)00884838085183(21)B1RCVN, (01)00884838085183(21)B1W8DH, (01)00884838085183(21)B21XTP, (01)00884838085183(21)B21XXQ, (01)00884838085183(21)B25VWD, (01)00884838085183(21)B2Y9PD, (01)00884838085183(21)B2Y9W3, (01)00884838085183(21)B1RCZK, (01)00884838086579(21)B2C76J, (01)00884838085183(21)B2D30D, (01)00884838085183(21)B2792J, (01)00884838085183(21)B2D36X, (01)00884838085183(21)B278QM, (01)00884838085183(21)B21Y7X, (01)00884838085183(21)B1ZJVN, (01)00884838085183(21)B1RCRC, (01)00884838074231(21)B1RCWC, (01)00884838074231(21)B1RCQL, (01)00884838074231(21)B1RCMH, 010088483808518321B2D2RX, (01)00884838086579(21)B2C768, (01)00884838085183(21)B2D2DX, (01)00884838085183(21)B21Y85, 010088483808518321B279D9, (01)00884838085183(21)B1RCW9, (01)00884838085183(21)B1RCNG, (01)00884838085183(21)B21XRB, (01)00884838085183(21)B1RD54; Serial No. B25VV3, B21XVK, B1ZJVG, B2D31R, B21XXK, B25VX0, B21Y07, B21Y6L, B21XYW, B1RCNL, B21Y64, B21YF6, B2D34Z, B1RCVN, B1W8DH, B21XTP, B21XXQ, B25VWD, B2Y9PD, B2Y9W3, B1RCZK, B2C76J, B2D30D, B2792J, B2D36X, B278QM, B21Y7X, B1ZJVN, B1RCRC, B1RCWC, B1RCQL, B1RCMH, B2D2RX, B2C768, B2D2DX, B21Y85, B279D9, B1RCW9, B1RCNG, B21XRB, B1RD54.
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- Transducer S4-1 989605458221Philips Ultrasound LLC · Transducer, ultrasonic, diagnostic2 recalls0 reports
- Transducer S4-1 989605458222Philips Ultrasound LLC · Transducer, ultrasonic, diagnostic2 recalls0 reports
- Transducer S4-1 989605477101Philips Ultrasound LLC · Transducer, ultrasonic, diagnostic2 recalls0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 97643).
- Z-1618-2026 · Open, ClassifiedPhilips 3D6-2 Ultrasound Transducer
- Z-1620-2026 · Open, ClassifiedPhilips L12-5 Ultrasound Transducer
- Z-1622-2026 · Open, ClassifiedPhilips Mini Multi TEE Ultrasound Transducer
- Z-1623-2026 · Open, ClassifiedPhilips OMNI II TEE Ultrasound Transducer
- Z-1624-2026 · Open, ClassifiedPhilips OMNI III TEE Ultrasound Transducer
- Z-1626-2026 · Open, ClassifiedPhilips S5-2 Ultrasound Transducer
- Z-1627-2026 · Open, ClassifiedPhilips X3-1 Ultrasound Transducer
- Z-1628-2026 · Open, ClassifiedPhilips X7-2 Ultrasound Transducer
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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