Recall Z-0765-2016— Philips Electronics North America Corporation

Name: FDA recall Z-0765-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-03

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2015-11-03, terminated 2016-08-19. It names one FDA 510(k) clearance: K102005. Product: Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.. Reason: Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the electromagnetic brake, leading to a full stop of the C-arc. Because of improper adjustment and tolerances, when the C-arc is initially stopped in an unbalanced position, the air gap of the brake can become too large, resulting in continued C-arc movement (C-arc is looking for balanced position)..

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-11-03
Terminated: 2016-08-19
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K102005 — ALLURA XPER OR TABLE SERIESPhilips Medical Systems North America, Inc.·cleared 2010-08-09

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

Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.

Reason for recall

Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the electromagnetic brake, leading to a full stop of the C-arc. Because of improper adjustment and tolerances, when the C-arc is initially stopped in an unbalanced position, the air gap of the brake can become too large, resulting in continued C-arc movement (C-arc is looking for balanced position).

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