Home / Recalls / PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. / Z-2229-2026

Z-2229-2026 Class II Ongoing

Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Best

FDA device recall Z-2229-2026 was initiated by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. on April 28, 2026 and is designated Class II. 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 co… The recall status is ongoing. Affected quantity: 25 units (11 US, 14 OUS).

Recall Details

Product Type: Devices
Report Date: May 27, 2026
Initiation Date: April 28, 2026
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 25 units (11 US, 14 OUS)

Product Description

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 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 Pattern

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, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Malaysia, Maldives, Malta, Martinique, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam, Yemen;

Code Information

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;

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