FDAFDA · Food and drugs·Recall number Z-1257-2017
The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator.
Published March 15, 2017 · Recall initiated: January 13, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Physio-Control, Inc.
- Distributor
- Worldwide Distribution - US (nationwide) and in the following countries: Bahrain, Belize, Cambodia, Chile, China, C¿te d'Ivoire, Ecuador, Germany, Honduras, Hong Kong, India, Indonesia, Jamaica, Myanmar, Netherlands, Niger, Philippines, Saudi Arabia, Senegal, Singapore, Sri Lanka, Thailand, Tunisia, Ukraine, and Zambia.
- Lot
- Affected Product Part Numbers: 320371500XX. There are 133,330 affected serial numbers.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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