The Recall Desk

FDA (Devices) recall action 81047

Siemens Healthcare Diagnostics, Inc. recalled 9 products on 2018-10-31

The FDA (Devices) publishes a recall like this one as 9 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 9 pages.

Products
9
Announced
2018-10-31
Critical
0
Units
3,204

Why these products were recalled

The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

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.

States named across these recalls

1–9 of 9