Z-0833-2012

GE eXplore Locus Micro CT cabinet x-ray system model RS9-80. CT Scanner for laboratory mice or other research

Name: Z-0833-2012 GE eXplore Locus Micro CT cabinet x-ray system model RS9-80. CT Scanner for laboratory mice or other research
Creator: GE Healthcare, LLC
Published: 2011-01-31
License: https://open.fda.gov/license/

GE Healthcare / initiated 2011-01-31 / Terminated

FDA source

GE Healthcare, LLC began a recall of GE eXplore Locus Micro CT cabinet x-ray system model RS9-80. CT Scanner for laboratory mice or other research on 2011-01-31. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0833-2012
Status: Terminated
Initiated: 2011-01-31
Posted: 2012-02-17
Terminated: 2012-09-06
Recalling firm: GE Healthcare
Product: GE eXplore Locus Micro CT cabinet x-ray system model RS9-80. CT Scanner for laboratory mice or other research.
Product code: RCE Cabinet X-Ray, Industrial
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.
FDA root cause: Radiation Control for Health and Safety Act
Action: 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.
Quantity in commerce: 21
Distribution: Worldwide Distribution
Product codes and lots: Part Number 5134163.

Product code RCE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)