Recall Z-2307-2016— Philips Electronics North America Corporation

Name: FDA recall Z-2307-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-19

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2016-07-19, terminated 2020-10-08. It names one FDA 510(k) clearance: K023441. Product: MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036. Reason: The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag.

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-07-19
Terminated: 2020-10-08
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K023441 — PHILIPS MULTIDIAGNOST ELEVAPhilips Medical Systems·cleared 2002-10-30

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

MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036

Reason for recall

The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag

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