FDA (Devices) recall action 88637
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
Customers were not notified of previous recalls associated with various defibrillator models.
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.
Customers of Philips HeartStart FRx defibrillators were not notified of previous recalls associated with various defibrillator models. This is a Class II medical device recall.
Philips North America LLC is recalling 15 units of the HeartStart HS1 OnSite Defibrillator (Models M5066A and M5067A) due to failure to notify customers of previous recalls associated with these devices.
Philips HeartStart FR2+ Defibrillators (models M3860A and M3861A) were not accompanied by notifications about previous recalls. Affected customers should contact Philips for information about prior safety issues.
Philips is recalling nine units of the HeartStart HS1 Home Defibrillator (Model M5068A) because customers were not notified of previous recalls associated with various defibrillator models.