PRN 50-M+ — Class II medical device recall Z-0866-2016
Terminated recall by Gsi Group Inc, reported 2016-03-02, distributed nationwide. The item was recalled due to an increased user/patient risk of exposure to fire and/or electrical shock due to
| Recall number | Z-0866-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gsi Group Inc, Bedford, MA, United States |
| Recall initiated | 2015-12-02 |
| Classified | 2016-02-24 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2018-06-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BS, CA, DE, FI, FR, GB, HK, IE, IN, IT, JP, KR, MX, PE, SA, SG, TW |
| Quantity | 2,257 units |
| Model numbers | 2062759-001 |
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.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0866-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.