Recall Z-2115-2016— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-2115-2016
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: K033326. Product: Ingenuity Core, model # 728326; 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 causing injury to patients, operators, by-standers and 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

K033326 — PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEMPhilips Medical Systems, Inc.·cleared 2003-10-29

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

Ingenuity Core, model # 728326; 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 causing injury to patients, operators, by-standers and service personnel.

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