—#73640

Product

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

FDA product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K050996
Affected lot / code info: S/N: 102, 125, 127, 129, 130, 134, 137, 147, 157, and 159.

Why it was recalled

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)

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

Medtronic Navigation notified service engineers to retest units for compliance.

Recalling firm

Firm: Medtronic Navigation, Inc.
Address: 300 Foster St, Littleton, Massachusetts 01460-2017

Distribution

Distribution pattern: CA, DC, LA, FL. IN, OH, PA, VA

Timeline

Recall initiated: 2008-06-30
Posted by FDA: 2008-09-26
Terminated: 2008-12-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73640. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.