Recall Z-2111-2016— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-2111-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-21

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2016-06-21, terminated 2018-07-02. It names one FDA 510(k) clearance: K033357. Product: Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.. Reason: Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack and cause injury to patients, operators, by standers or service personnel..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2016-06-21
Terminated: 2018-07-02
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K033357 — ACQSIM-MULTISLICE-CT, MODEL 453567042271Philips Medical Systems (Cleveland), Inc.·cleared 2004-01-09

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 Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.

Reason for recall

Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack and cause injury to patients, operators, by standers or service personnel.

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