Recall Z-1874-2016— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-1874-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-08

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2016-04-08, terminated 2018-07-02. It names one FDA 510(k) clearance: K033326. Product: Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.. Reason: The firm became aware of a problem where the system may not map Varian drive after CT user logout/login..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2016-04-08
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 128 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Reason for recall

The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.

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