BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System Generating 2D and 3D images of human anatomy for surgical app
FDA device recall Z-2034-2008 · posted 2008-09-26 · Terminated
Recall details
- Recalling firm
- Medtronic Navigation, Inc.
- 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)
- Action taken
- Medtronic Navigation notified service engineers to retest units for compliance.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 10 units
- Distribution
- CA, DC, LA, FL. IN, OH, PA, VA
- Date initiated
- 2008-06-30
- Date posted
- 2008-09-26
- Date terminated
- 2008-12-04
- Location
- Littleton, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| O-ARM IMAGING SYSTEM (K050996) | Breakaway Imaging, LLC | 2005-05-05 |