Recall Z-2066-2025
Philips Ultrasound, Inc · initiated May 28, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Philips X7-2t Transducer.
Codes / lots: Model No. 989605350454, 989605361911, 989605414122, 989605461941, 989605350452, 989605350451, 989605455171, 989605350453, 989605438611; UDI: Unique Device Identifier (UDI), (01)00884838061668(21)B144RL, (01)00884838061668(21)B28L3F, (01)00884838061668(21)B26MZ9, (01)00884838061668(21)B3DT21, (01)00884838061668(21)B3DP0K, (01)00884838061668(21)B2JJFV, (01)00884838061668(21)B0T9J4, (01)00884838061668(21)B2XCH6, (01)00884838061668(21)B3DRBG, (01)00884838061668(21)B21DC0, (01)00884838061668(21)B21C1Q, (01)00884838061668(21)B13R5Z, (01)00884838061668(21)B2JJM6, (01)00884838061668(21)B2JJ71, (01)00884838061668(21)B1ZGT3, (01)00884838061668(21)B1C112, (01)00884838061668(21)B1JMPG, (01)00884838061668(21)B1ZH27, (01)00884838061668(21)B1XZ2L, (01)00884838061668(21)B3DT3K, (01)00884838061668(21)B20TVK, (01)00884838061668(21)B1BDJG, (01)00884838061668(21)B1TY40, (01)00884838061668(21)B1ZGM3, (01)00884838061668(21)B1J660, (01)00884838061668(21)B1TCB5, (01)00884838061668(21)B238J6, (01)00884838061668(21)B2VQN4, (01)00884838061668(21)B1ZH4K, (01)00884838061668(21)B191TJ, (01)00884838061668(21)B21DL6, (01)00884838061668(21)B1TB82, (01)00884838061668(21)B23F6J, (01)00884838061668(21)B15PQH…
Reason for recall
Ultrasound transducer devices were refurbished beyond their useful life.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-2066-2025
- Initiated
- May 28, 2025
- Posted by FDA
- July 2, 2025
- Product code
- ITX – Transducer, Ultrasonic, Diagnostic
- Quantity
- 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, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines…
- Recalling firm
- Philips Ultrasound, Inc, Reedsville, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2048-2025 Class II | Philips 3D9-3v Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | 05/28/2025Open, Classified |
| Z-2049-2025 Class II | Philips C5-1 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | 05/28/2025Open, Classified |
| Z-2050-2025 Class II | Philips C5-2 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | 05/28/2025Open, Classified |
| Z-2051-2025 Class II | Philips C9-5EC Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | 05/28/2025Open, Classified |
| Z-2052-2025 Class II | Philips eL18-4 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | 05/28/2025Open, Classified |
| Z-2053-2025 Class II | Philips eL18-4 EMT Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | 05/28/2025Open, Classified |
| Z-2054-2025 Class II | Philips L12-3 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | 05/28/2025Open, Classified |
| Z-2055-2025 Class II | Philips L12-4 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | 05/28/2025Open, Classified |
| Z-2056-2025 Class II | Philips L8-4 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | 05/28/2025Open, Classified |
| Z-2057-2025 Class II | Philips L9-3 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | 05/28/2025Open, Classified |
| Z-2058-2025 Class II | Philips S5-1 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | 05/28/2025Open, Classified |
| Z-2059-2025 Class II | Philips S7-2 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | 05/28/2025Open, Classified |
| Z-2060-2025 Class II | Philips S7-3t Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | 05/28/2025Open, Classified |
| Z-2061-2025 Class II | Philips S8-3t Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | 05/28/2025Open, Classified |
| Z-2062-2025 Class II | Philips V6-2 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | 05/28/2025Open, Classified |
| Z-2063-2025 Class II | Philips VL13-5 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | 05/28/2025Open, Classified |
| Z-2064-2025 Class II | Philips X5-1 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | 05/28/2025Open, Classified |
| Z-2065-2025 Class II | Philips X6-1 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | 05/28/2025Open, Classified |
| Z-2067-2025 Class II | Philips X8-2t Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | 05/28/2025Open, Classified |
| Z-2068-2025 Class II | Philips XL14-3 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | 05/28/2025Open, Classified |