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Health product recall

LIFEPAK 1000 Defibrillator (2014-06-05)

Starting date:
June 5, 2014
Posting date:
July 15, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-40559

Recalled products

  1. LIFEPAK 1000 Defibrillator

Reason

Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 and the device has shut down due to a very low battery. A defibrillator in this scenario has the potential to fail to deliver a shock; with the result that therapy is not delivered. The operating manual may contribute to customers not replacing the battery when required. The readiness display may indicate a low battery charge when it should indicate a very low battery charge. Batteries at both low and very low star of charge must be replace with a fully charged battery.

Affected products

A. LIFEPAK 1000 Defibrillator

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 99425-XXXXXX
Companies
Manufacturer

Physio-Control, Inc.,

11811 Willows Road North East,

Redmond

98052

Washington

UNITED STATES