The LIFEPAK 1000 defibrillator is intended for use by recall
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…
Why was The LIFEPAK 1000 defibrillator is intended for use by recalled?
The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Affected Product Part Numbers: 320371500XX. There are 133,330 affected serial numbers.
- 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…
- Recalling firm
- Physio-Control, Inc.
- Quantity
- total 133,330 units (50,046 units in the US)
- Distribution
- 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.
- Recall date
- March 15, 2017
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)