FDA (Devices) recall action 97072
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.
Certain Spectrum infusion pumps may have an incorrect version of software.
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.
Baxter SIGMA Spectrum Infusion Pump V6 units are being recalled because certain pumps may have an incorrect version of software. 14 units are affected.
Baxter SIGMA Spectrum Infusion Pump V8 units are being recalled because certain pumps may have an incorrect version of software. 28 units are affected.