Recall Z-0866-2016— Gsi Group Inc
Class II · Terminated
Class II FDA medical device recall by Gsi Group Inc, initiated 2015-12-02, terminated 2018-06-06. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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.
- Recalling firm
- Gsi Group Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-02
- Terminated
- 2018-06-06
- Firm location
- Bedford, MA, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.