Reported Jul 31, 2013 · Terminated
The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory…
Physio Control, 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: Physio Control, Inc. · 11811 Willows Rd Ne · Redmond, WA · 98052-2003
Is this the product you have?
- The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The LIFEPAK 500 AED is intended for use by personnel who are authorized by a physician/medical director and is intended for use in the pre-hospital and workplace and community environments.
- Lot codes and dates
- PART NUMBERS
3011790-0015683011790-0015743011790-0016273011790-001634and 3011790-001650
- SERIAL NUMBERS OUTSIDE the US
41232265412322674123226941232270412322714123227241238207412382084130114541301370413013714130137241301373and 41301374
- SERIAL NUMBERS IN THE US
125 of 125 codes
411349054113490641134907411359824113598341135984411359914113599241135993411359944113599541135996411359974113599841135999411360004113600141136002411360034113600441136005411360064113600741136008411360094113601041136011411360124113601341136014411360154113601641136017411360184113601941136020411360214113602241136023411360244113602541136026411360274113602841136029411360304113603141136033411360344113603541136036411360374113603841136039411360404113606041136061411360624113606341136064
- PART NUMBERS
- Amount recalled
- 139 total (125 units in the US and 14 units outside US)
Where it was sold
Why it was recalled
The LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to an assembly error. If affected, the malfunction would be the result of internal shorting on a printed circuit board assembly and could render the device inoperable.
This product could cause temporary or reversible health problems — stop using it.
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