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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Product Detail

Product Description Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System.
Recall Number Z-0881-2013
Classification Class II
Code Info The EBW Serial Numbers subject to software updates are as follows: 8222, 8235, 8270, 8838, 8841, 8862, 9014, 9019, 9127, 10331, 10348, 10402, 10705, 10749, 10827, 11002, 11362, 11365, 11588, 11597, 11652, 11693, 11704, 11724, 11725, 11828, 11857, 11861, 11945, 11949, 11950, 11951, 11952, 11953, 11954, 11955, 11956, 11957, and 11979.
Product Distributed Qty 39 units
Reason For Recall Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Projection data set is used in the radiation therapy workflow, then this may result in unintended delivery of radiation to healthy tissue and/or failure to deliver radiation to the target lesion.

Event Detail

Event Id 63822
Product Type Devices
Status Ongoing
Recalling Firm Philips Medical Systems (Cleveland) Inc
City Cleveland
State OH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-24
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA including AK, AK, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, OA MA, MD MI, MN, MO, MS, NC, D, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV; Internationally to Canada and other countries..
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