Z-0861-2021 Class II Terminated
FDA device recall Z-0861-2021 was initiated by Siemens Healthcare Diagnostics, Inc. on December 2, 2020 and is designated Class II. Reason for recall: Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results The recall status is terminated (terminated June 6, 2024). Affected quantity: 2405 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 20, 2021
- Initiation Date
- December 2, 2020
- Termination Date
- June 6, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2405 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Peru, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Fed. Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E. Ukraine, United Kingdom, Uruguay, Vatika City, Vietnam.