FDA (Devices) recall action 75417
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Possible overheating of power cord plugs used to connect to FlexLab and Aptio Automation systems.
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 448 Aptio Automation Modules because power cord plugs may overheat when connected to FlexLab and Aptio systems.
Siemens Healthcare Diagnostics is voluntarily recalling 448 FlexLab Automation Modules. The recall was initiated by the firm and is classified as Class II.