Gsi Group Inc: Medical Device Recall in 2016 - (Recall #: Z-0866-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 2, 2015

Date Posted: March 2, 2016

Recall Number: Z-0866-2016

Event ID: 72936

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

Status: Terminated

Product Quantity: 2257 units

Code Information:

Serial Number range: 1801405 through 1918761

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

Voluntary or Mandated:

Voluntary: Firm initiated