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Low riskFDA DeviceClass III

Philips S4-1 Ultrasound Transducer recalled for clarification of useful life labeling

Philips is recalling certain S4-1 ultrasound transducers to clarify and update labeling that defines how long these devices can be safely used in clinical settings. No injuries have been reported. The recall affects 41 units distributed nationwide.

From the FDA notice · Read the official notice ↗ · All Philips recalls

What to do

  1. If you use a Philips S4-1 ultrasound transducer, check the serial number against the list of affected units
  2. Contact Philips for updated labeling or guidance on useful life for your specific transducer
  3. Review the product's useful life information before clinical use
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Philips S4-1 Ultrasound Transducer
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 11 products — see all of them.

Details

Units affected
41 units
Illnesses reported
None reported
Manufactured in
1 Echo Dr, Reedsville, PA, United States
Classification
Class III
Recall number
Z-1625-2026

In the FDA's words

Description
Philips S4-1 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the field. 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. Distribution: US Nationwide distribution. Affected quantity: 41 units
Hazard
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

11 products in this recall

Philips ultrasound transducers recalled for unclear useful-life labeling

Philips is recalling 11 ultrasound transducer models to clarify and update labeling that defines how long these devices are expected to remain in use. The recall was filed for clarification, and no injuries have been reported.

The agency lists each product separately. Check every one you might have.

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