FDA (Devices) recall action 90985
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.
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
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.
Boston Scientific is recalling 7 EMBLEM S-ICD Model A209 subcutaneous defibrillators due to a software defect that displays inaccurate battery capacity information. Patients may not realize when their device's battery requires replacement.
Boston Scientific's EMBLEM MRI S-ICD implantable defibrillators contain a software defect with an incorrect manufacturing date that causes inaccurate battery capacity display. The recall affects 142 devices distributed worldwide.