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.
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
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Quantity: 41 units. Distribution: US Nationwide. Model Nos.: 989605458221, 989605458222, 989605477101. UDIs include: (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
The recall is to clarify and label the useful life of ultrasound transducers in the field. The notice does not describe a separate functional defect or patient injury but aims to standardize labeling for lifecycle information.
No injuries or incidents have been reported.
1. Stop using the product. 2. Follow the recall instructions provided by Philips Ultrasound, Inc. 3. Contact Philips Ultrasound, Inc or your healthcare provider for instructions. 4. Refer to the FDA recall notice for additional guidance: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1625-2026.
Philips Ultrasound, Inc recall inquiries: refer to the FDA recall page for official contact details. FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1625-2026
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