Recall Z-2306-2016— Philips Electronics North America Corporation

Name: FDA recall Z-2306-2016
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: K911098. Product: UroDiagnost; x-ray system. Product Code: 708033. 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

K911098 — PHILIPS URO DIAGNOST MRFPhilips Medical Systems, Inc.·cleared 1991-07-03

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

UroDiagnost; x-ray system. Product Code: 708033

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.