FDA Device recall Z-2359-2025
C8-5 Transducer Probe
- FDA Device
- Class III
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class III recall of C8-5 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-2359-2025 |
| 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
C8-5 Transducer Probe
Reason
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Identifiers
| code_info | Model No. 989605391922, 989605438441, 989605440822, 989605387852, 989605387281, 989605391092, 8500-1664-01, 98960535234…Model No. 989605391922, 989605438441, 989605440822, 989605387852, 989605387281, 989605391092, 8500-1664-01, 989605352343, 989605352342; UDI: (01)00884838061514(21)B1Q41K, (01)00884838061514(21)B1QB9Z, (01)00884838061514(21)B2859G, (01)00884838061514(21)B2YTR3, (01)00884838061514(21)B2YTTV, (01)00884838061514(21)B3F4JN, (01)00884838061514(21)F08DZC, 010088483806151421F01W6L, (01)00884838061514(21)F04XX6, (01)00884838061514(21)F0FCL7, (01)00884838061514(21)B3B4RD, (01)00884838061514(21)B288HM, (01)00884838061514(21)B2FXYD, (01)00884838061514(21)B2FXZB, (01)00884838061514(21)B1P4JM, (01)00884838061514(21)B1P9ZG, (01)00884838061514(21)B338L3, (01)00884838061514(21)F0C7VZ, (01)00884838061514(21)F0FHNV, (01)00884838061514(21)F0KM0Y, (01)00884838061514(21)B22GYC, (01)00884838061514(21)B21T06, (01)00884838067691(21)B26NBY, (01)00884838061514(21)B34J00, (01)00884838061514(21)B2FXJK, (01)00884838067691(21)B2882D, (01)00884838067691(21)B288VM, (01)00884838067691(21)B2FY2G, (01)00884838061514(21)B |
|---|
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-2359-2025%22
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