Device product
BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001
Z-0085-2021
Product summary
- Event
- Event 86399
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2623 (US); 3735 (ex-US)
- Official record key
device-enforcement:Z-0085-2021
Official wording
Reason: Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket
Code information: All units
Distribution pattern: Nationwide Foreign: Canada, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, UK, Algeria, Argentina, Aruba, Australia, Bahrain, Bosnia-Herz., Brazil, Chile, China, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, Egypt, El Salvador, Hong Kong, India, Israel, Japan, Jordan, Kazakhstan, Kuwait, Malaysia, Martinque, Mexico, Monaco, Morocco, Namibia, New Caledonia, New Zealand, Oman, Pakistan, Panama, Peru, Philippines, Russia, Saudi Arabia, Singapore, S. Africa, S. Korea, Taiwan, Thailand, Ukraine, UAE, Vietnam
Derived failure modes
-
Unknown
Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket