Device product
Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259
Z-1186-2016
Product summary
- Event
- Event 73352
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1125 units
- Official record key
device-enforcement:Z-1186-2016
Official wording
Reason: On August 15, 2012, Sorin informed consignees via letter of changes made to create Version 12 of the Heater-Cooler 3T IFU. The revised IFU included enhancements to achieve water quality that meets the standard for German drinking water.
Code information: All Serial Numbers for Item Number 16-02-81, 16-02-82, 16-02-85;
Distribution pattern: Worldwide Distribution - US Nationwide, VA/govt/military
Derived failure modes
-
Unknown
On August 15, 2012, Sorin informed consignees via letter of changes made to create Version 12 of the Heater-Cooler 3T IFU. The revised IFU included enhancements to achieve water quality that meets the standard for German drinking water.