NA
Ge Medical Systems Information Technologies, Inc. · Model B1X5-REC · UDI-DI 00840682180689
DSF
Prescription
10
510(k) clearances
6
Adverse events
1
Recalls
51
Facilities
Description
ASSY THERMAL RECORDER W/ PRINTER VALUE MONITOR(4TH EMC)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-12-02 | Gsi Group Inc | 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 |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.