Atellica IM 1300 Analyzer, Material Number 11066001
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics, Inc. is recalling 277 units of the Atellica IM 1300 Analyzer (Material Number 11066001) due to multiple issues identified in the system software that required an update. The affected devices were distributed across 36 US states and Puerto Rico, as well as to numerous foreign countries including Canada, Australia, and several European and South American nations.
The recall record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
There were multiple issues identified in the system software which required an update.
Reason for recall: There were multiple issues identified in the system software which required an update. 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, Do Quantity: 277 Lot/code info: UDI: 00630414007960
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.