Z-0866-2016Class II

PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01

Name: Z-0866-2016 PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01
Creator: Gsi Group Inc
Published: 2015-12-02
License: https://open.fda.gov/license/

Gsi Group Inc / initiated 2015-12-02 / Terminated / root cause: manufacturing process

FDA source

Gsi Group Inc began a recall of 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... on 2015-12-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0866-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-02
Posted: 2016-02-24
Terminated: 2018-06-06
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.
Product code: DSF Recorder, Paper Chart
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
Root cause tag: manufacturing process
FDA 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 [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.
Quantity in commerce: 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
Product codes and lots: Serial Number range: 1801405 through 1918761

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0866-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0866-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24

Product code DSF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)