FDAFDA · Food and drugs·Recall number Z-2405-2012
Precise Digital Accelerator Delivery of radiation to defined target volumes
Published September 26, 2012 · Recall initiated: August 6, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- Elekta, Inc.
- Distributor
- 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
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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