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US Endoscopy · Model 00713100 · UDI-DI 00724995195045
NWI
Prescription
0
510(k) clearances
2
Adverse events
1
Recalls
13
Facilities
Description
The gi4000 Introduction Kit contains Argon Gas Canister, ArConnect Argon Probe Connector, ArC Smart Probe, Touchsoft Coagulator Monopolar Probe, Active Cord and a Water Bottle Holder.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2004-09-24 | Datascope Corp | Software anomaly where the variable heart rates may be displayed inaccurately or intermittent 'dashes' may be displayed when the patient's heart rate is derived from ECG. |
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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.