GE eXplore Locus Micro CT cabinet x-ray system model RS9-80. CT Scanner for laboratory mice or other research.
FDA device recall Z-0833-2012 · posted 2012-02-17 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- Product fails to comply with the federal performance standard for cabinet x-ray systems (Title 21 CFR 1020.40(c)(1)(i)). Specifically, the x-ray emission limit of 0.5 milliroentgen in one hour could be exceed. Highest emission measured was 3 mR/hr.
- Action taken
- GE Healthcare will notify purchasers of the problem, the affected product, instructions for users, and specify the maximum emission rate measured. GE Healthcare will bring defective systems into compliance free of charge. This will be done via Field Modification Instructions IFMI) 11101 which is scheduled for deployment on March 1, 2011 with an estimated completion date of July 1, 2011.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- RCE
- Quantity affected
- 21
- Distribution
- Worldwide Distribution
- Date initiated
- 2011-01-31
- Date posted
- 2012-02-17
- Date terminated
- 2012-09-06
- Location
- Waukesha, WI
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