FDA Device recall Z-2354-2025
C5-2 Lumify Transducer Probe
- FDA Device
- Class III
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class III recall of C5-2 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-2354-2025 |
| 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
C5-2 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. 989605450353, 989605450352, 989605477131, 989605450351, 989605451181, 989605427371; UDI: 010088483808517621F0…Model No. 989605450353, 989605450352, 989605477131, 989605450351, 989605451181, 989605427371; UDI: 010088483808517621F0FYRG, (01)00884838085176(21)B3H57K, (01)00884838068766(21)B1W1CR, (01)00884838086555(21)B2C7Z5, (01)00884838085176(21)F07VCW, (01)00884838085176(21)F0J0P8, (01)00884838061828(21)B1MBZM, (01)00884838068766(21)B1W1NG, (01)00884838085176(21)B1MC3H, (01)00884838085176(21)B1QHPM, (01)00884838085176(21)B1W13D, (01)00884838085176(21)B1W153, (01)00884838085176(21)B27BC5, (01)00884838085176(21)B3PH0F, (01)00884838085176(21)B3R48C, (01)00884838085176(21)F02N98, (01)00884838085176(21)F07PWD, (01)00884838085176(21)F07TZ0, (01)00884838085176(21)F07Y64, (01)00884838085176(21)F081Y3, (01)00884838085176(21)F082NG, (01)00884838085176(21)F082NP, (01)00884838085176(21)F0855V, (01)00884838085176(21)F088RF, (01)00884838085176(21)F089MZ, (01)00884838085176(21)F089N6, (01)00884838085176(21)F08GBG, (01)00884838085176(21)F08GBX, (01)00884838085176(21)F08HWH, (01)00884838085176(21)F08KFK, (01)0 |
|---|
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-2354-2025%22
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