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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The S4-1 ultrasound transducer is used in medical imaging to obtain diagnostic ultrasound images. Hospitals and clinics rely on such transducers daily for patient care.
The hazard relates to labeling clarifications about the useful life of the transducer, not an explicit functional defect or immediate patient harm in the notice.
This recall is not described as part of a broader industry pattern.
The recall affects hospital equipment inventories and requires immediate stop-use actions and adherence to manufacturer instructions to ensure proper lifecycle management.
FDA recall page for Z-1625-2026 and Philips recall notices.
Remediation timelines vary by facility; manufacturers typically coordinate replacements or updates within weeks to months.
Document inventory checks, correspondence with Philips, and any remediation actions taken.
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
No injuries or incidents have been reported.
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