Recall Z-0019-2014— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-0019-2014
Creator: U.S. Food and Drug Administration
Published: 2013-07-22

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2013-07-22, terminated 2014-09-25. It names one FDA 510(k) clearance: K083498. Product: MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.. Reason: A pinch point at the end of the table top can cause injury..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2013-07-22
Terminated: 2014-09-25
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K083498 — PHILIPS MODEL MX 16 SLICE CT SYSTEMPhilips Medical Systems (Cleveland), Inc.·cleared 2008-12-17

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

MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.

Reason for recall

A pinch point at the end of the table top can cause injury.

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