Reported Mar 26, 2014 · Terminated
Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A,…
Philips Medical Systems North America Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems North America Inc. · 22100 Bothell Everett Hwy · Bothell, WA · 98021-8431
Is this the product you have?
- Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs)
- Product Usage
The models M5066AM5067Aand M5068A are designed for use on a
- person in sudden cardiac arrest who is-Unresponsive when shaken -Not breathing normally If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HS1. If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the special infant/child pads. If the child appears older/larger, use the adult pads. Do not delay treatment to determine the child s exact age or weight. If in doubt, use the adult pads. Models M5066A (for HS1 Onsite), M5067A (OnSite) , and M5068A (for HS1 Home)
- Lot codes and dates
- SERIAL
- NUMBERS OF UNITS DISTRIBUTED IN THE USA
2,713 of 2,713 codes
A13G-00001A13G-00002A13G-00003A13G-00004A13G-00005A13G-00006A13G-00007A13G-00008A13G-00009A13G-00010A13G-00011A13G-00012A13G-00013A13G-00014A13G-00015A13G-00016A13G-00017A13G-00018A13G-00019A13G-00020A13G-00021A13G-00022A13G-00023A13G-00024A13G-00025A13G-00026A13G-00027A13G-00028A13G-00029A13G-00030A13G-00031A13G-00032A13G-00033A13G-00034A13G-00035A13G-00036A13G-00037A13G-00038A13G-00039A13G-00040A13G-00041A13G-00042A13G-00043A13G-00044A13G-00045A13G-00046A13G-00047A13G-00048A13G-00049A13G-00050A13G-00051A13G-00052A13G-00053A13G-00054A13G-00055A13G-00056A13G-00057A13G-00058A13G-00059A13G-00060
- Amount recalled
- 5075 units total (2724 units in the US and 2351 units outside the US)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or both contact pins may be contaminated by residue from the soldering process. This contamination could prevent an adequate connection between the pads cartridge and the AED. If poor contact between the pads cartridge and AED occurs, the device may be unable to deliver therapy in an emergency.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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