Atellica IM 1600 Analyzer, Material Number 11066000
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics, Inc. is recalling 366 units of the Atellica IM 1600 Analyzer (Material Number 11066000) due to multiple issues identified in the system software that required an update. The affected devices were distributed across 37 U.S. states and Puerto Rico, as well as to multiple foreign countries including Canada, Australia, Argentina, Brazil, and others.
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: 366 Lot/code info: UDI: 00630414002026
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.