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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, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Model #882473; GEMINI TF 64 - Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Recall Number Z-0882-2013
Classification Class II
Code Info The affected GEMINI systems are identified with the following Serial Numbers: GEMINI LXL Model # 882412, Serial Numbers: 14702 and 14707; GEMINI TF 16 Model #882470, Serial Numbers: 7129, 7121, 7123, 7128, 7096, 7133, 7185, 7187, 7226, and 7220; GEMINI TF 16, Model #882473, Serial Numbers: 7150, and and 7237;GEMINI TF 64, Model #882471, Serial Numbers: 7103, 7126, 7132, 7158, 7160, 7164, 7175, 7178, 7179, 7218, 7229, 7221, 7245, 7550, 7255, and 7256.
Product Distributed Qty 30 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..