PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allu…

Recall date

August 22, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3167-2024

FDA classification

Class II

Brand / firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Sold / distributed

Nationwide, Canada and Worldwide: Albania Algeria Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovina Brazil Brunei Darussalam Bulgaria Cambodia Cayman Islands Chile China Colombia Costa Rica C¿te D'Ivoire Croatia Cuba Curacao Cyprus Czec…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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