Device product
Atellica Sample Handler Prime, Material Number 11069001
Z-1301-2019
Product summary
- Event
- Event 82602
- Status
- Terminated
- Classification
- Class II
- Quantity
- 474
- Official record key
device-enforcement:Z-1301-2019
Official wording
Reason: There were multiple issues identified in the system software which required an update.
Code information: UDI: 00630414002026
Distribution pattern: The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, NE, NH, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA, WV, WY, and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Nigeria, Norway, P.R. China, Pakistan, Poland, Portugal Republic of Korea, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, UK, and Vietnam.
Derived failure modes
-
Unknown
There were multiple issues identified in the system software which required an update.