FDA (Devices) recall action 95160
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.
This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life.
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.
Zoe Medical is recalling 1506 units of the Spacelabs Ultraview DM4 Vital Signs Monitor due to inadequate labeling about damaged or expired battery risks. The lack of proper warnings could affect device safety.
Zoe Medical is recalling 6,429 Spacelabs Ultraview DM3 Vital Signs Monitors because labeling does not adequately warn users about risks from damaged or expired batteries.