Device product
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.
Z-0866-2016
Product summary
- Firm
- Gsi Group Inc
- Event
- Event 72936
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2257 units
- Official record key
device-enforcement:Z-0866-2016
Official wording
Reason: 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
Code information: Serial Number range: 1801405 through 1918761
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
Derived failure modes
-
Unknown
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