Philips HeartStart HS1 Defibrillators Recalled for Manual Clarification
Philips is recalling HeartStart HS1 defibrillators to clarify maintenance information 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, but the source text indicates the issue is related to clarifying maintenance information in the manual rather than a direct safety defect causing injury. This aligns with the 'Moderate' criteria for voluntary precautionary recalls or minor labeling/documentation issues.
Plain-English summary
Philips Medical Systems North America Co. is recalling specific models of HeartStart HS1 Automated External Defibrillators (AEDs), including the FRx, OnSite, and HeartStart Home series. The recall covers devices shipped between December 2005 and July 2012. The affected models include M5066A, M5067A, and M5068A, manufactured under Philips and Laerdal brands.
The recall was initiated to clarify information in the Owner's Manual and to emphasize the importance of maintaining the devices. Philips determined that customers needed to be kept informed about proper maintenance procedures for these life-saving devices.
Approximately 613,000 devices were shipped worldwide, including in the United States, Japan, and Malaysia. Consumers should check their device model and serial numbers against the recall list and refer to the updated Owner's Manual for maintenance guidance.
The recalled product
- Product
- Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the
- Category
- Medical Device — Defibrillator
- Hazard
- Affected units
- 613,000
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 (20)
- M5067A and M5068A: 1) M5066A (referred to as Onsite or HS1)
- Philips brand
- 510 (k) = K020715
- sold nationally and internationally
- serial numbers range from A021-00038 through A12E-03490
- with 306
- 108 total devices. 2) M5067A
- Philips brand 510(k) = K040904
- serial numbers range from A05C-00727 through A12D-01406
- with 978 total devices. 3) M5068A
- Philips brand 510(k) = K020715
- serial numbers range from A021J-00207 through A12E-01900
- with 22
- 760 total devices 4) M5066A
- Laerdal brand
- sold internationally
- serial numbers range from A021-00036 through A12D-02148
- with 60
- 433 total devices. 5) M5067A
- sold as Home device- cleared for OTC on initial 510(k) = K040904
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.
See all 2 products in this recall →Related recalls
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See all →- ModeratePhilips HeartStart FRx AED Recall for Maintenance Manual Clarification
FDA (Devices) · 2013-01-16
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