Recall Z-1301-2019
Siemens Healthcare Diagnostics, Inc. · initiated March 7, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Atellica Sample Handler Prime, Material Number 11069001
Codes / lots: UDI: 00630414002026
Reason for recall
There were multiple issues identified in the system software which required an update.
FDA-determined cause: Under Investigation by firm
Action taken
Urgent Medical Device Correction notification letters dated 3/7/19 were sent to customers.
Details
- Recall number
- Z-1301-2019
- Initiated
- March 7, 2019
- Terminated
- August 20, 2020
- Product code
- JGS – Electrode, Ion Specific, Sodium
- Quantity
- 474
- Distribution
- 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…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Tarrytown, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1299-2019 Class II | Atellica IM 1300 Analyzer, Material Number 11066001There were multiple issues identified in the system software which required an update. | 03/07/2019Terminated |
| Z-1300-2019 Class II | Atellica IM 1600 Analyzer, Material Number 11066000There were multiple issues identified in the system software which required an update. | 03/07/2019Terminated |