BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat Panel Detector (FPD): product code 882454.

FDA device recall Z-1982-2014 · posted 2014-07-02 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

Flat Panel Display (FPD) failed to remain securely locked in the deployed position.

Action taken

Philips sent an Field Safety Notice dated June 17, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This Field Safety Notice (FSN) 88200490 and Addendum is intended to inform you about the following: " what the problem is and under what circumstances it can occur " the actions that should be taken by the customer / user in order to prevent risks for patients or users " the actions planned by Philips to correct the problem. If you need any further information or support concerning this issue, please contact your local Philips Healthcare representative: For North America and Canada contact the Customer Care Solutions Center (1-800-722-9377: follow the prompts). thcare is informing the consignee of this issue through a Field Safety Notice 88200490. The US consignees will receive this notice via certified mail and Philips Healthcare Key Market representatives will distribute the FSN internationally. Additionally, a Field Service Engineer will contact each site to schedule a time to conduct the appropriate field safety correction through Field Change Order (FCO) 88200490 that will address the above identified issue.

Root cause

Device Design

Status

Terminated

Product code

KPS

Quantity affected

407

Distribution

Worldwide Distribution - USA including the states of : AZ, CA, CO, DC, FL, GA, IL, MA, MD, MN, MO, MS, MT, NC, NJ, NY,OH, OK, OR, PA, TX, VT, WA,WI. Government Facilities: AZ, CA, CO, FL, HI, IA, KY,

Date initiated

2014-06-23

Date posted

2014-07-02

Date terminated

2015-09-24

Location

Cleveland, OH

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