CLASS II Device recall · Reported 2 Mar 2016 · FDA Enforcement Report

Prn 50-m+, Ge recalled by Gsi Group

Gsi Group is recalling Prn 50-m+, Ge, distributed nationwide in the US. The recall was initiated on 2 Dec 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Number range: 1801405 through 1918761

Quantity recalled2257 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0866-2016
FDA event ID: 72936
Recalling firm: Gsi Group, Bedford, MA
Classification: Class II
Status: Terminated
Recall initiated: 2 Dec 2015
FDA classified: 24 Feb 2016
Reported: 2 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

2 Dec 2015	Recall initiated by company
24 Feb 2016	Classified by FDA	+84 days
2 Mar 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Puerto Rico

Questions about this recall

Is Prn 50-m+, Ge recalled?

Yes. Gsi Group recalled Prn 50-m+, Ge on 2 Dec 2015. The recall is Class II and its status is Terminated. Recall number Z-0866-2016.

Why was it 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

Which lots are affected?

Serial Number range: 1801405 through 1918761

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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