Device product
Alinity m System, Part No. 08N53-002
Z-0461-2022
Product summary
- Event
- Event 89167
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 742 devices
- Official record key
device-enforcement:Z-0461-2022
Official wording
Reason: There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.
Code information: Alinity m System, Model 08N53-002, all serial numbers
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, Colombia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Malawi, Malaysia, Mexico, Montenegro, Morocco, Mozambique, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Uganda, United Kingdom, and Vietnam.
Derived failure modes
-
Device software or design
software issue