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OPTIVISTA
HOYA CORPORATION · Model EPK-i7010 · UDI-DI 04961333233618
PEA
Prescription
1
510(k) clearances
609
Adverse events
5
Recalls
12
Facilities
Description
PENTAX Medical Video Processor EPK-i7010
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-09 | Pentax of America Inc | Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure. |
| 2025-07-16 | Pentax of America Inc | During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dark. Users have observ |
| 2025-01-29 | Pentax of America Inc | During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users |
| 2025-01-29 | Pentax of America Inc | During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users |
| 2025-01-29 | Pentax of America Inc | During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users |
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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.