FDA (Devices) recall action 82602
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
There were multiple issues identified in the system software which required an update.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Siemens Healthcare Diagnostics is recalling 366 Atellica IM 1600 Analyzers due to multiple issues identified in the system software that required an update.
Siemens Healthcare Diagnostics is recalling 277 Atellica IM 1300 Analyzers due to multiple issues identified in the system software that required an update.
Siemens Healthcare Diagnostics is recalling 474 Atellica Sample Handler Prime units due to multiple issues identified in the system software that required an update.