Enforcement Report - Week of September 26, 2012
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Event Detail
| Event ID | 62917 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Elekta, Inc. |
| City | Norcross |
| State | GA |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-06 |
| Initial Firm Notification of Consignee or Public | Other |
| Distribution Pattern | Nationwide Distribution including AL, AZ, CA, CO, CT, FL, GA, IL, IA, MD, MA, MI, MN, NE, NV, NJ, NM, NY, ND, OH, OK, OR, PA, VA, SC, TN TX, WA, WV, WI and Puerto |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Precise Digital Accelerator Delivery of radiation to defined target volumes | 151587, 105932, 151574, 151363, 151076, 151110, 151369, 151504, 105941, 151418, 151674, 151566, 151259, 151636, 151568, 151390, 151258, 151584, 151391, 151317, 151522, 151055, 151423, 151507, 151623, 151627, 151640, 151479, 151340, 151178, 151467, 151514, 151051, 151411, 151216, 151430, 151173, 151616, 151595, 151141, 151433, 151611, 151151, 151653, 151515, 151360, 151675, 151538, 151024, 151523, 151521, 151260, 151519, 151432, 151410, 151371, 151084, 151435, 151387, 151530, 151328, 151176, 151080, 151626, 151567, 151598, 151601, 151269, 151396, 151557, 151558, 105982, 151160, 151634, 151394, 151398, 151540, 151632, 151446, 151301, 151038, 151441, 151256, 151168, 151156, 151157, 151155, 151579, 151412, 105984, 151053, 151359, 151585, 151326, 151327, 151443, 151250, 151130, 151245, 151416, 151664, 151672, 151074, 151352, 151298, 151545, 151628, 105803, 151362, 151073 | Class II | There have been a small number of instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts. | 110 | Z-2405-2012 |
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