Philips HeartStart FRx AED Recall for Maintenance Manual Clarification
Philips is recalling HeartStart FRx AEDs to clarify maintenance instructions in the Owner's Manual.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a documentation issue (clarifying maintenance instructions) rather than a direct physical defect or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Philips Medical Systems North America Co. is recalling approximately 201,598 Philips HeartStart FRx and Laerdal branded FRx automated external defibrillators (AEDs). The affected models are the Philips HeartStart FRx 861304 and the Laerdal branded FRx 861305. These devices were shipped between December 2005 and July 2012 and are distributed nationwide in the United States, as well as in Japan and Malaysia.
The recall was initiated to clarify information in the Owner's Manual and to keep customers informed about the maintenance of their devices. Philips determined there is a need to emphasize the importance of proper maintenance for these AEDs.
Consumers should refer to the updated Owner's Manual for accurate maintenance instructions. The recall covers specific serial number ranges for both the Philips and Laerdal models, which are detailed in the official recall notice.
The recalled product
- Product
- Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Us
- Hazard
- Affected units
- 201,598
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)
- 1)Philips brand FRx Model Number 861304 under 510(k) K050004
- sold nationally and Internationally
- Serial numbers range from BO4L-00001 through B12F-00286 and represents 181
- 226 devices
- 2) Laerdal brand FRx Model Number 861305 unfrt 510(k) K050004
- serial numbers range from B04L-00013 through B12E-04135 and represents 20
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Philips Medical Systems North America Co. Phillips under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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