Recall Z-3167-2024— PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Name: FDA recall Z-3167-2024
Creator: U.S. Food and Drug Administration
Published: 2024-08-22

Class II · Ongoing

Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2024-08-22. It names one FDA 510(k) clearance: K002016. Product: 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. Reason: 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..

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Classification: Class II
Status: Ongoing
Initiated: 2024-08-22
Firm location: Best, Netherlands

510(k) clearances named in this recall

1 on FDA's record

K002016 — PHILIPS INTEGRIS ALLURAPhilips Medical Systems North America, Inc.·cleared 2000-09-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.