Enforcement Report - Week of September 26, 2012
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Product Detail
| Product Description | Precise Digital Accelerator Delivery of radiation to defined target volumes |
|---|---|
| Recall Number | Z-2405-2012 |
| Classification | Class II |
| Code Info | 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 |
| Product Distributed Qty | 110 |
| Reason For Recall | 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. |
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 |
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