Recall Z-1503-2014— Philips Medical Systems, Inc.

Name: FDA recall Z-1503-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-17

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2014-03-17, terminated 2020-09-16. It names one FDA 510(k) clearance: K982795. Product: Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85. Reason: The footboard of Patient support for stitching can be fixed in upper position. When the fix clamp (hook) is not correctly adjusted into its correct position, the footboard is not securely held..

Recalling firm: Philips Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-03-17
Terminated: 2020-09-16
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K982795 — PHILIPS BUCKY VISIONPhilips Medical Systems, Inc.·cleared 1998-11-24

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

Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85

Reason for recall

The footboard of Patient support for stitching can be fixed in upper position. When the fix clamp (hook) is not correctly adjusted into its correct position, the footboard is not securely held.

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