FDA Device recall Z-2064-2025
Philips X5-1 Transducer
- FDA Device
- Class II
- ongoing
- Published 2025-07-09
On 2025-07-09 the FDA classified a Class II recall of Philips X5-1 Transducer by Philips Ultrasound, citing ultrasound transducer devices were refurbished beyond their useful life.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2064-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-28 |
| Published | 2025-07-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Ultrasound |
| Distribution | US |
Product
Philips X5-1 Transducer.
Reason
Ultrasound transducer devices were refurbished beyond their useful life.
Identifiers
| code_info | Model No. 989605400802; UDI: (01)00884838061422(21)B2XMDQ, (01)00884838061422(21)B3H27D, (01)00884838061422(21)B2ZXZB,…Model No. 989605400802; UDI: (01)00884838061422(21)B2XMDQ, (01)00884838061422(21)B3H27D, (01)00884838061422(21)B2ZXZB, (01)00884838061422(21)B26JC4, (01)00884838061422(21)B3GYXN, (01)00884838061422(21)B2ZXD8, (01)00884838061422(21)B3GJB2, (01)00884838061422(21)B2MQZ3, (01)00884838061422(21)B3L198, (01)00884838061422(21)B3KC2D, (01)00884838061422(21)B3MTN1, (01)00884838061422(21)B2894C; Serial No. B2XMDQ, B3H27D, B2ZXZB, B26JC4, B3GYXN, B2ZXD8, B1CGYC, B3GJB2, B2MQZ3, B3L198, B3KC2D, B3MTN1, B2894C, B1FHTZ. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2064-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.