BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box. BrightView XC

FDA device recall Z-0089-2014 · posted 2013-10-28 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

Philips received reports from the field that the Flat Panel Detector (FPD) does not always remain securely latched in the stowed position.

Action taken

Philips Healthcare sent an Urgent - Medical Device Correction letter (Field Safety Notice (FSN 88200462), dated August 30, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the information contained in the notice with all members of their staff who need to be aware of the contents of the letter. Customers were asked to retain a copy with the equipment instruction for use. Additionally, a Field Service Engineer will contact each site to schedule time to implement the Field Change Order. A Field Service Engineer will visit the site to install the corrected software. The firm will be tracking the progress.Customers with questions were instructed to contact their local Philips representataive or local Philips Healthcare office. For North America and Canada contact the Customers Care Solutions Center at 1-800-722-9377, option 5.

Root cause

Device Design

Status

Terminated

Product code

KPS

Quantity affected

371 units

Distribution

Worldwide Distribution - USA including AZ, CA, CO, DC, DE, FL, GA, HI, IA, IL, KY, MA, MD, MN, MO, MS, MT, NC, NJ, ND, NE, NV, NY, OH, OK, OR, PA, SD, TX, VT, WA, and WI. Internationally to Canada, Al

Date initiated

2013-09-03

Date posted

2013-10-28

Date terminated

2014-08-18

Location

Cleveland, OH

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