FDA Device recall Z-2229-2026
Integris-Allura system
- FDA Device
- Class II
- ongoing
- Published 2026-05-27
On 2026-05-27 the FDA classified a Class II recall of Integris-Allura system by Philips Medical Systems Nederland B V, citing the deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leak….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2229-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-28 |
| Published | 2026-05-27 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integris Allura 15 & 12 (monoplane) (722043), INTEGRIS Allura 15-12 (biplane) (722044), Integris-Allura 9 (722018), Integris-Allura 9 (Biplane) (722021), Integris CV Cesar-Powerpack (722030), Integris H5000 C / Allura 9C (722016);
Reason
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.
Identifiers
| code_info | 1. Integris CV Cesar-Powerpack-Visub-Nicol; Model: 722030; UDI-DI: N/A; Serial Numbers: 4888270, 59, 0, 33; 2. Integris…1. Integris CV Cesar-Powerpack-Visub-Nicol; Model: 722030; UDI-DI: N/A; Serial Numbers: 4888270, 59, 0, 33; 2. Integris Allura 15 & 12 (monoplane) (722043); UDI-DI: N/A; Serial Numbers: 365, 18151, 176, 239, 407, 426, 0; 3. INTEGRIS Allura 15-12 (biplane) (722044); UDI-DI: N/A; Serial Numbers: 86322, 30, 66; 4. Integris-Allura 9 (722018); UDI-DI: N/A; Serial Numbers: 26, 85; 5. Integris-Allura 9 (Biplane) (722021); UDI-DI: N/A; Serial numbers: 22, 75, 25, 108; 6. Integris H5000 C / Allura 9C (722016); UDI-DI: N/A; Serial Numbers: 4059001008, 4807240, S01H003553/000001; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2229-2026%22
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