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U.S. Department of Health and Human Services

Class 2 Device Recall Paper Chart Recorder

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  Class 2 Device Recall Paper Chart Recorder see related information
Date Initiated by Firm December 02, 2015
Create Date February 24, 2016
Recall Status1 Terminated 3 on June 06, 2018
Recall Number Z-0866-2016
Recall Event ID 72936
Product Classification Recorder, paper chart - Product Code DSF
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.
Code Information Serial Number range: 1801405 through 1918761
Recalling Firm/
Manufacturer		 Gsi Group Inc
125 Middlesex Tpke
Bedford MA 01730-1409
Manufacturer 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
FDA Determined
Cause 2		 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 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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