Brilliance Big Bore Computed Tomography X-Ray Systems, M/N 728243, 728244, Distributed by: Philips Medical System, Cleve

FDA device recall Z-1366-2012 · posted 2012-04-05 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

TumorLOC will save the incorrect contour when the user saves the contour while in the edit mode, and the software does not force the user to exit the edit mode before saving. In TumorLOC, when saving while a contour is in edit mode, that contour will shift to the slice corresponding to the most recently drawn contour of the last organ in the Organ list.

Action taken

Philips sent an Urgent - Medical Device Correction letters to all affected customers. The letter identified the product, what the problem is and under what circumstances it can occur, important information for the continued safe and proper use of the affected equipment, and actions to be taken to minimize the effect of the problem. Philips instructed their customers to put a copy of the letter with their "Instructions for Use" manual. For question contact your local Philips representative or local philips healthcare office. For North America and Canada contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Site Id or follow the prompts).

Root cause

Software design (manufacturing process)

Status

Terminated

Product code

JAK

Quantity affected

570 units

Distribution

Worldwide Distribution - USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, O

Date initiated

2012-01-26

Date posted

2012-04-05

Date terminated

2013-02-22

Location

Cleveland, OH