Recall Z-2176-2018— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-2176-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-30

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2018-03-30, terminated 2020-04-14. It names one FDA 510(k) clearance: K012009. Product: Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system. Reason: The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would require medical intervention to preclude permanent impairment in certain scenarios..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2018-03-30
Terminated: 2020-04-14
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

1 on FDA's record

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 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system

Reason for recall

The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would require medical intervention to preclude permanent impairment in certain scenarios.

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