PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integris Allura 15 & 12 (monoplane) (722043),

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Domestic: Nationwide; International: Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Georgia, Germany, Greece, Hong Kong, Hung Quantity: 25 units (11 US, 14 OUS) Lot/code info: 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;

Source

Official record: FDA (Device enforcement) ↗

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