Recall Z-1464-2014— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-1464-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-06

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2014-03-06, terminated 2014-11-05. It names one FDA 510(k) clearance: K033326. Product: Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.. Reason: A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions would intermittently not complete..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2014-03-06
Terminated: 2014-11-05
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, Philips Medical Systems (Cleveland), Inc.

Reason for recall

A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions would intermittently not complete.

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