Device product
IMRI SHORT ATTACHMENT Product Usage: Pneumatic system
Z-1997-2017
Product summary
- Event
- Event 76059
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14
- Official record key
device-enforcement:Z-1997-2017
Official wording
Reason: Supplied Directions for Use (DFU) did not contain a recommended service interval.
Code information: All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0093; Part No. IMRI-SHORT.
Distribution pattern: Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Derived failure modes
-
Unknown
Supplied Directions for Use (DFU) did not contain a recommended service interval.