Recall Z-2208-2012— Philips Healthcare Inc.

Name: FDA recall Z-2208-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-11

Class II · Terminated

Class II FDA medical device recall by Philips Healthcare Inc., initiated 2012-07-11, terminated 2017-01-23. It names 2 FDA 510(k) clearances: K031535, K970640. Product: Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use.. Reason: Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could not stop the tilting movement of the table base due tol hardware or software errors..

Recalling firm: Philips Healthcare Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-07-11
Terminated: 2017-01-23
Firm location: Andover, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K031535 — PHILIPS EASYDIAGNOST ELEVAPhilips Medical Systems North America Co.·cleared 2003-06-17
K970640 — PHILIPS EASY DIAGNOSTPhilips Medical Systems North America, Inc.·cleared 1997-03-21

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 Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use.

Reason for recall

Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could not stop the tilting movement of the table base due tol hardware or software errors.

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