Precise Digital Accelerator recallZ-2405-2012 · Elekta, Inc. · initiated Aug 6, 2012
Class II Terminated All recalls posted in September 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Elekta, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Elekta sent an Important Field Safety Notice dated August, 2012 to inform users that inspection and possibly bolt replacement needs to be carried out. Users should return the signed acknowledgement to Elketa, and an inspection should be carried out under FCO20002103053. For questions customers should call +44(0)1293 654200. For questions regarding this recall call 770-300-9725.
Recall details
- Recall number
- Z-2405-2012
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 6, 2012
- Posted by the FDA
- Sep 19, 2012
- Recalling firm
- Elekta, Inc.
- Quantity
- 110
- Product code
- IYE
- FDA submissions
- K051932
- Distribution
- 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 description
Precise Digital Accelerator Delivery of radiation to defined target volumes
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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
Other devices under the same FDA submission
1 device cleared under K051932 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA 1525717Elekta Limited · Accelerator, linear, medical1 recall3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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