Z-0866-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 2, 2016
- Initiation Date
- December 2, 2015
- Termination Date
- June 6, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2257 units
Product Description
PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner. This device is not intended for home use.
Reason for Recall
The item was recalled due to an increased user/patient risk of exposure to fire and/or electrical shock due to the failure of the PRN 50-M+ Digital Writer
Distribution Pattern
Worldwide Distribution - US Nationwide including Puerto Rico; Internationally: Australia, Bahamas, Canada, Germany, Finland, France, Great Britain, Hong Kong, India, Ireland, Italy, Japan, South Korea, Mauritus, Mexico, Peru, Saudi Arabia, Singapore, Taiwan, United Arab Emirates & United Kingdom
Code Information
Serial Number range: 1801405 through 1918761