Reported May 27, 2026 · Ongoing
Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030),…
Philips Medical Systems Nederland B.v.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Veenpluis 6 · Best · N/A
Is this the product you have?
- 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)
- Lot codes and dates
6 of 6 products
Products covered by this recall Model / number Product as published 722030Integris CV Cesar-Powerpack-Visub-Nicol; ; UDI-DI: N/A; Serial Numbers: 4888270, 59, 0, 33 — Integris Allura 15 & 12 (monoplane) (722043); UDI-DI: N/A; Serial Numbers: 365, 18151, 176, 239, 407, 426, 0 — INTEGRIS Allura 15-12 (biplane) (722044); UDI-DI: N/A; Serial Numbers: 86322, 30, 66 — Integris-Allura 9 (722018); UDI-DI: N/A; Serial Numbers: 26, 85 — Integris-Allura 9 (Biplane) (722021); UDI-DI: N/A; Serial numbers: 22, 75, 25, 108 — Integris H5000 C / Allura 9C (722016); UDI-DI: N/A; Serial Numbers: 4059001008, 4807240, S01H003553/000001 - Amount recalled
- 25 units (11 US, 14 OUS)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- GA
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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