Z-1257-2017 Class I Terminated
FDA device recall Z-1257-2017 was initiated by Physio-Control, Inc. on January 13, 2017 and is designated Class I. Reason for recall: The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage. The recall status is terminated (terminated August 22, 2019). Affected quantity: total 133,330 units (50,046 units in the US).
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.