The Brilliance Workspace Portal is a software component of the Computed Tomography X-Ray System. The Brilliance Workspac

FDA device recall Z-1219-2012 · posted 2012-03-16 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

Incorrect Standardized Uptake Value ("SUV") values are displayed in two instances: 1. After loading PET data (with a Slope value different than 1) into the Quick Review (QR) application from a remote device; and 2. During the loading the above mentioned type of PET data into the CT viewer application from a remote device.

Action taken

The Philips Healthcare, sent an "URGENT-Medical Device Correction" Field Safety Notice dated February 08, 2012 to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to review the information with all members of their staff and to retain a copy with the equipment Instruction for Use. The letter notifies the customers that a Field Service Engineer will be contacting them to schedule a visit to implement the corrective action by installing the software update version 2.6.1. If you need further information or support concerning this issue, please 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

Status

Terminated

Product code

KPS

Quantity affected

822

Distribution

Worldwide distributions: USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, VA, NY, OH, OK, OR, P

Date initiated

2012-02-23

Date posted

2012-03-16

Date terminated

2013-02-22

Location

Cleveland, OH

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