Recall Z-1359-2015— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-1359-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-05

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2015-02-05, terminated 2016-08-25. It names 2 FDA 510(k) clearances: K060937, K033326. Product: Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128 & Ingenuity CT), Philips Medical Systems, Cleveland, OH. Reason: Philips discovered that a software defect exists in marketed product wherein the sign indication of the longitudinal position of some types of scan is inverted..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2015-02-05
Terminated: 2016-08-25
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

2 on FDA's record

K060937 — BRILLIANCE VOLUMEPhilips Medical Systems (Cleveland), Inc.·cleared 2006-06-05
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

Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128 & Ingenuity CT), Philips Medical Systems, Cleveland, OH

Reason for recall

Philips discovered that a software defect exists in marketed product wherein the sign indication of the longitudinal position of some types of scan is inverted.

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