FDA Device recall Z-1626-2026
Philips S5-2 Ultrasound Transducer
- FDA Device
- Class III
- ongoing
- Published 2026-04-01
On 2026-04-01 the FDA classified a Class III recall of Philips S5-2 Ultrasound Transducer 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-1626-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-09-05 |
| Published | 2026-04-01 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Philips Ultrasound |
| Distribution | US |
Product
Philips S5-2 Ultrasound Transducer
Reason
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Identifiers
| code_info | Model No. 989605368393; (01)00884838064638(21)B0C824; Serial No. B0C824. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Other recalls by Philips Ultrasound
- Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
FDA Device · Class II · 2026-09-30 · Philips Ultrasound - Philips C9-4 Ultrasound Transducer
FDA Device · Class III · 2026-04-01 · Philips Ultrasound - Philips X7-2 Ultrasound Transducer
FDA Device · Class III · 2026-04-01 · Philips Ultrasound - Philips L17-5 Ultrasound Transducer
FDA Device · Class III · 2026-04-01 · Philips Ultrasound - Philips OMNI III TEE Ultrasound Transducer
FDA Device · Class III · 2026-04-01 · Philips Ultrasound
All Philips Ultrasound recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1626-2026%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.