FDA Medical Device Recalls (openFDA)
Gsi Group Inc: 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.
- Recall number
- Z-0866-2016
- Recalling firm
- Gsi Group Inc
- 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.
- Status
- Terminated
- Initiated
- 2015-12-02
- Posted
- not on file
- Terminated
- 2018-06-06
- 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
- Root cause
- Nonconforming Material/Component
- 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 customerservice@insidesales-solutions.com. 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.
- Quantity
- 2257 units
- Distribution
- 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
- Lot, serial or model codes
- Serial Number range: 1801405 through 1918761
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DSF
- Firm FEI
- 3007083974
- Firm city
- Bedford
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28