Philips eL18-4 EMT Transducer.
FDA device recall Z-2053-2025 · posted 2025-07-02 · Open, Classified
Recall details
- Recalling firm
- Philips Ultrasound, Inc
- Reason for recall
- Ultrasound transducer devices were refurbished beyond their useful life.
- Action taken
- An URGENT Medical Device Recall notification dated 5/28/25 was mailed to consignees. The notification informs consignees that Philips Ultrasound will be replacing transducers that were refurbished beyond their useful life with a new transducer. Consignees may continue to use affected devices while awaiting replacement; consignees should use devices in accordance with their intended use and per the instructions provided int he User Manual. Users should perform visual inspection and electrical safety testing as indicated in the User Manual; if a device does not pass inspection, it should be removed from clinical use. Consignees are asked to return the completed Response Form and circulate the provided notification to all users to ensure awareness. A copy of the recall notification should be kept with affected transducers until their replacement. Consignees with any questions can contact the Customer Care Solutions Center at 1-800-722-9377. Additional consignees were identified and notified via URGENT Medical Device Recall Notification on 9/5/25.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- ITX
- Quantity affected
- 5,230 units
- Distribution
- Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong,
- Date initiated
- 2025-05-28
- Date posted
- 2025-07-02
- Location
- Reedsville, PA
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