Device product
VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110. Intended for use in the in vitro measurement of a variety of analytes of clinical interest.
Z-1348-2016
Product summary
- Event
- Event 73429
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,101 Total units (1,043 domestically & 1,058 internationally)
- Official record key
device-enforcement:Z-1348-2016
Official wording
Reason: The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situation where a module that is intended to be de-energized will remain energized only if the associated AC power cord is unplugged.
Code information: Product Codes: 6802413, 6802915 (Refurbished) Serial numbers: J56000024 - J56002387
Distribution pattern: Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy & Spain.
Derived failure modes
-
Unknown
The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situation where a module that is intended to be de-energized will remain energized only if the associated AC power cord is unplugged.