Device product
Owandy Radiology I -MAX Touch 3D X-ray
Z-0129-2016
Product summary
- Event
- Event 71958
- Status
- Terminated
- Classification
- Class II
- Quantity
- I-MAX Touch 3D- 6 installed
- Official record key
device-enforcement:Z-0129-2016
Official wording
Reason: It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330).
Code information: p/n 9306251191 and 9306651191
Distribution pattern: US Distribution
Derived failure modes
-
Unknown
It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330).