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.
FDA Recall Z-0866-2016 · Posted None
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Recalling FirmGsi Group Inc
Recall StatusTerminated
Product CodeDSF
Date Initiated2015-12-02
Date Terminated2018-06-06
Product Quantity2257 units
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
Firm Action
On December 2, 2015 GSI Group Corp. distributed Medical Device Correction Notice letter and confirmation forms dated November 18, 2015 to their customers via FedEx. GSI Group Corp. warned customers about a potential safety issue associated with the flammability and fluid ingress rating of the outer enclosure material. Customers are advised to follow all intended usage, cleaning and maintenance instructions that are found in the PRN 50-M+ Digital Writer Technical Manual. It is recommended that customers complete and return the attached Medical Device Correction Confirmation form via email to [email protected]. GSI Group Corp. will provide a correction at no charge. Once the confirmation form is received, GSI Group Corp. will make arragements to send replacements. Customers with questions can call 781-266-5700.
Root Cause
Nonconforming Material/Component
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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