Gsi Group product recalled over fire hazard

Recall date

December 2, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Gsi Group Inc recalls PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart R…

Recall number

Z-0866-2016

FDA classification

Class II

Brand / firm

Gsi Group Inc

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.