FDA Device recall Z-3167-2024
System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 72201…
- FDA Device
- Class II
- ongoing
- Published 2024-09-25
On 2024-09-25 the FDA classified a Class II recall of System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 72201… by Philips Medical Systems Nederland B V, citing potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3167-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-22 |
| Published | 2024-09-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722018 Integris Allura 9 722017 Integris H5000 F / Allura 9F 722016 Integris H5000 C / Allura 9C
Reason
Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
Identifiers
| code_info | Model Product UDI-DI: N/A 722044 INTEGRIS Allura 15-12 (biplane) 72…Model Product UDI-DI: N/A 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722018 Integris Allura 9 722017 Integris H5000 F / Allura 9F 722016 Integris H5000 C / Allura 9C All serial numbers |
|---|
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-3167-2024%22
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