BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System Generating 2D and 3D images of human anatomy for surgical applications.
Hazard
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)
What You Should Do
Remedy
Medtronic Navigation notified service engineers to retest units for compliance.
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Products
BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System
Generating 2D and 3D images of human anatomy for surgical applications.
- Brand
- Medtronic Navigation, Inc.
- UPC
- S/N: 102, 125, 127, 129, 130, 134, 137, 147, 157, and 159.
Units Affected
10 units