FDA (Devices) recall action 98189
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.
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
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.
Datascope is recalling the CS300 IABP running software version C.01 because the battery runtime and cycle specifications in the device's Instructions for Use need to be updated.
Datascope is recalling the CS100 IABP running software version Q.01 because the battery runtime and cycle specifications in the device's Instructions for Use need to be updated.