Physio-Control Recalls LIFEPAK 1000 Defibrillators for Unexpected Power-Offs
Physio-Control is recalling 133,330 LIFEPAK 1000 defibrillators worldwide because they may unexpectedly power off during use.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 per the rubric.
Plain-English summary
Physio-Control, Inc. is recalling the LIFEPAK 1000 defibrillator due to complaints that the device is unexpectedly powering off during usage. The recall covers a total of 133,330 units, with 50,046 units distributed in the United States and the remainder distributed worldwide in countries including Bahrain, Belize, Cambodia, Chile, China, Côte 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.
The affected product part numbers are 320371500XX. The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician or medical director and are trained in CPR and the use of the device. The agency has classified this recall as Class I.
Users should stop using the affected devices and contact Physio-Control for further instructions on repair or replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Physio-Control, Inc.
- Category
- Medical Device — Defibrillator
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Affected Product Part Numbers: 320371500XX. There are 133
- 330 affected serial numbers.
Distribution
Distributed nationwide across the United States.
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