Reported Mar 2, 2016 · Terminated

PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart…

Gsi Group Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Gsi Group Inc · 125 Middlesex Tpke · Bedford, MA · 01730-1409

Is this the product you have?

    • PRN 50-M+
    • GE part number 2062759-001
    • manufacturer part number 600-23310-01
  • Product UsageThe 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
Lot codes and dates
  • Serial Number range1801405 through 1918761
Amount recalled
2257 units

Where it was sold

  • Nationwide
  • PR

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 6, 2018 · Data as of Sep 19, 4:44 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.