Z-2034-2008

BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System Generating 2D and 3D images of human anatomy for...

Name: Z-2034-2008 BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System Generating 2D and 3D images of human anatomy for...
Creator: Medtronic Navigation, Inc.
Published: 2008-06-30
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2008-06-30 / Terminated

FDA source

Medtronic Navigation, Inc. began a recall of BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System Generating 2D and 3D images of human anatomy for surgical applications on 2008-06-30. The reason FDA records is "Failure to of affected units to comply with EER/AKR limits due to misinterpretation of the measurement requirements specified in 21 CFR 1020.32 (d) (3) (iii)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2034-2008
Status: Terminated
Initiated: 2008-06-30
Posted: 2008-09-26
Terminated: 2008-12-04
Recalling firm: Medtronic Navigation, Inc
Product: BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System Generating 2D and 3D images of human anatomy for surgical applications.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: Failure to of affected units to comply with EER/AKR limits due to misinterpretation of the measurement requirements specified in 21 CFR 1020.32 (d) (3) (iii)
FDA root cause: Radiation Control for Health and Safety Act
Action: Medtronic Navigation notified service engineers to retest units for compliance.
Quantity in commerce: 10 units
Distribution: CA, DC, LA, FL. IN, OH, PA, VA
Product codes and lots: S/N: 102, 125, 127, 129, 130, 134, 137, 147, 157, and 159.

Product code JAA

K050996Class IIO-Arm Imaging SystemBreakaway Imaging, LLC / cleared 2005-05-05

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)