Recall Z-2210-2013— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-2210-2013
Creator: U.S. Food and Drug Administration
Published: 2013-07-05

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2013-07-05, terminated 2015-09-15. It names 2 FDA 510(k) clearances: K033326, K012009. Product: Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & Brilliance CT 64 M/N 728231, Philips Healthcare, Cleveland, OH 44143. Intended to produce cross-sectional images of the body by computer reconstruction.. Reason: The patient support may move in an unintended manner if the footswitch cover impinges on the footswitch..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2013-07-05
Terminated: 2015-09-15
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

2 on FDA's record

K033326 — PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEMPhilips Medical Systems, Inc.·cleared 2003-10-29
K012009 — MX8000 IDT CT SYSTEMMarconi Medical Systems, Inc.·cleared 2001-09-13

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

Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & Brilliance CT 64 M/N 728231, Philips Healthcare, Cleveland, OH 44143. Intended to produce cross-sectional images of the body by computer reconstruction.

Reason for recall

The patient support may move in an unintended manner if the footswitch cover impinges on the footswitch.

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