Recall Z-1251-2015— Philips Medical Systems, Inc.

Name: FDA recall Z-1251-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-23

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2015-01-23, terminated 2016-06-07. It names one FDA 510(k) clearance: K141381. Product: Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Models: 712210, 712211. Reason: Improper installation of Tube arm, and Wall stand may cause it to fall down, Improper installation of table may cause it to float..

Recalling firm: Philips Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-01-23
Terminated: 2016-06-07
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K141381 — DURADIAGNOSTPhilips Healthcare (Suzhou) Co., Ltd.·cleared 2014-06-12

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

Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Models: 712210, 712211

Reason for recall

Improper installation of Tube arm, and Wall stand may cause it to fall down, Improper installation of table may cause it to float.

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