FDA Device recall Z-2392-2025
S4-1 Lumify Transducer Probe
- FDA Device
- Class III
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class III recall of S4-1 Lumify Transducer Probe by Philips Ultrasound, citing to provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2392-2025 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-07-03 |
| Published | 2025-09-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Ultrasound |
| Distribution | US |
Product
S4-1 Lumify Transducer Probe
Reason
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Identifiers
| code_info | Model No.989605458222, 989605477101, 989605458221; UDI: (01)00884838085183(21)B3G9Q2, (01)00884838074231(21)B1RCZ0, (01…Model No.989605458222, 989605477101, 989605458221; UDI: (01)00884838085183(21)B3G9Q2, (01)00884838074231(21)B1RCZ0, (01)00884838074231(21)B1RD8W, (01)00884838074231(21)B1RDD9, (01)00884838074231(21)B1W89Q, (01)00884838074231(21)B1W8D2, (01)00884838085183(21)B2D2YM, (01)00884838074231(21)B21YB6, (01)00884838085183(21)B35Y6X, (01)00884838085183(21)B36B15, (01)00884838085183(21)B36B6J, (01)00884838086579(21)B2C7BV, (01)00884838085183(21)F0BH9V, (01)00884838085183(21)F0DDFJ, (01)00884838085183(21)F0DDFL, (01)00884838085183(21)F0DDZD, (01)00884838085183(21)F0DDZF, (01)00884838085183(21)F0DF0H, (01)00884838085183(21)F0FFWW, (01)00884838085183(21)F0FMM0, (01)00884838085183(21)F0FQ22, (01)00884838085183(21)F0FQ79, (01)00884838085183(21)F0FQ7B, (01)00884838085183(21)F089PW, (01)00884838085183(21)B3VTP6, (01)00884838085183(21)B21XV4, (01)00884838085183(21)B2795N, (01)00884838085183(21)B2795P, (01)00884838085183(21)B279F3, (01)00884838085183(21)F03BG3, (01)00884838085183(21)F043BH, (01)0088483808 |
|---|
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-2392-2025%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.