Z-1257-2017 Class I Terminated

Recalled by Physio-Control, Inc. — Redmond, WA

Recall Details

Product Type
Devices
Report Date
March 15, 2017
Initiation Date
January 13, 2017
Termination Date
August 22, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
total 133,330 units (50,046 units in the US)

Product Description

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.

Reason for Recall

The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage.

Distribution Pattern

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.

Code Information

Affected Product Part Numbers: 320371500XX. There are 133,330 affected serial numbers.