Philips Defibrillators Recall: Customers Uninformed of Previous Recalls
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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving failure to notify customers of previous recalls. Although no illnesses or injuries are reported, this notification failure on a medical device creates a risk-of-harm situation where customers are unaware of previously identified issues.
Plain-English summary
Philips North America LLC has issued a recall of the HeartStart FRx defibrillator (Model 861304). This is an FDA Class II medical device.
The recall stems from a notification failure: customers were not notified of previous recalls associated with various defibrillator models. This left device users unaware of issues identified in earlier recall actions.
The affected devices have been distributed within the United States in California, Connecticut, Florida, Georgia, Indiana, Michigan, Missouri, New Jersey, New York, Ohio, Texas, and Washington. International distribution includes Australia, Canada, France, Germany, Japan, Norway, and Switzerland. Six units are involved in this recall.
Customers with affected devices should contact Philips North America LLC with their device model and serial number to obtain information about the previous recalls.
The recalled product
- Product
- Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304
- Manufacturer
- Philips North America LLC
- Category
- Medical Device — Defibrillator
- Hazard
- notification-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Model 861304 serial number: 0805164058
- B12C-03067
- B07I-01107
- B09D-01464
- B08L-00595
- B10I-03918
Distribution
Distributed in 12 states:
- CA
- CT
- FL
- GA
- IN
- MI
- MO
- NJ
- NY
- OH
- TX
- WA
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