Recall Z-3168-2024— PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Name: FDA recall Z-3168-2024
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: K050151. Product: System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Detector 708036 MultiDiagnost Eleva 708034 MultiDiagnost Eleva with Flat Detector 708032 MultiDiagnost Eleva. 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

K050151 — MULTIDIAGNOST ELEVAPhilips Medical Systems North America, Inc.·cleared 2005-02-09

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: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Detector 708036 MultiDiagnost Eleva 708034 MultiDiagnost Eleva with Flat Detector 708032 MultiDiagnost Eleva

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.