Pentax of America Inc — Pentax Medical Video Processor; Model Number: EPK-i8020c;
⚠️ 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 observed smoke like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient and may cause thermal injury to the patient s mucous membrane.
Is this relevant to me?
- Geography
- US, AZ, CA, DC, FL, IA, ID, IL, KS, MA, MD, MI, MO, NC, NJ, NM, NY, OK, PA, TX, WA
- Source agency
- FDA
- Category
- Health
- Published
- July 16, 2025
US Distribution to states of: AZ, CA, DC, FL IA, ID, IL, KS, MA, MD, MI, MO, NC, NJ, NM, NY, OK, PA, TX, WA.
What's affected?
- Product
- Pentax Medical Video Processor; Model Number: EPK-i8020c;
- Lot code
- Model Number: EPK-i8020c; UDI-DI: 04961333247974; Serial Numbers: B0023Z1657, D0023Z0245, D0023Z0206, D0023Z0125, D0023Z0123, D0023Z0119, D0023Z0118, D0023Z0117, D0023Z0114, D0023Z0112, D0023Z0109, D0023Z0108, D0023Z0011, C0023Z0087, C0023Z0085, C0023Z0074, C0023Z0072, C0023Z0021, B0023Z1712, B0023Z1711, B0023Z1670, B0023Z1665, B0023Z1659, B0023Z1653, B0023Z1628, b0023z1501, B0023Z1195, B0023Z1707, C0023Z0084, B0023Z1732, B0023Z1669, D0023Z0137, D0023Z0141, D0158Z0049, D0158Z0033, E0023Z0022, D0158Z0053, D0158Z0019, E0023Z0026, E0023Z0008, D0023Z0248, D0023Z0241, D0023Z0222, D0023Z0155, B0023Z1276, C0023Z0082, D0023Z0233, B0023Z1461, D0023Z0139, D0023Z0140, D0023Z0122, B0023Z1709, E0023Z0020, E0023Z0009, E0023Z0002, D0023Z0142, E0023Z0024, E0023Z0018, E0023Z0013, E0023Z0004, C0023Z0095, C0023Z0078, E0023Z0007, E0158Z0057, E0158Z0035, B0023Z1735, B0023Z1717, B0023Z1648, B0023Z1639, B0023Z1631, C0158Z0047, C0158Z0042, B0023Z1481, B0023Z1478, B0023Z1451, B0023Z1335, B0023Z1193, B0023Z1288, B0023Z1258, B0023Z1296, B0023Z1290, B0023Z1286, B0023Z1280, B0023Z1279, B0023Z1256, B0023Z1250, B0023Z1245, B0023Z1676, B0023Z1573, B0023Z1565, B0023Z1656, B0023Z1694, D0158Z0055, B0023Z1577, B0023Z1570, B0023Z1682, B0023Z1678, B0023Z1661, B0023Z1637, D0158Z0048, D0158Z0047, E0023Z0016, E0023Z0001, D0023Z0071, D0023Z0150, D0023Z0148, D0023Z0143, B0023Z1277, D0023Z0152, D0023Z0144, D0023Z0106, D0023Z0102, B0023Z1667, B0023Z1652, B0023Z1645, B0023Z1727, B0023Z1723, B0023Z1702, E0023Z0003, D0023Z0244, D0023Z0232, C0023Z0091, D0023Z0208, B0023Z1655, D0023Z0219, D0023Z0017, D0023Z0008, C0023Z0098, C0023Z0097, C0023Z0096, C0023Z0094, C0023Z0092, B0023Z1716, B0023Z1698, B0023Z1697, B0023Z1696, B0023Z1671, B0023Z1255, B0023Z1247, B0023Z1291, B0023Z1289, B0023Z1287, B0023Z1285, B0023Z1243;
Additional details
Model Number: EPK-i8020c; UDI-DI: 04961333247974; Serial Numbers: B0023Z1657, D0023Z0245, D0023Z0206, D0023Z0125, D0023Z0123, D0023Z0119, D0023Z0118, D0023Z0117, D0023Z0114, D0023Z0112, D0023Z0109, D0023Z0108, D0023Z0011, C0023Z0087, C0023Z0085, C0023Z0074, C0023Z0072, C0023Z0021, B0023Z1712, B0023Z1711, B0023Z1670, B0023Z1665, B0023Z1659, B0023Z1653, B0023Z1628, b0023z1501, B0023Z1195, B0023Z1707, C0023Z0084, B0023Z1732, B0023Z1669, D0023Z0137, D0023Z0141, D0158Z0049, D0158Z0033, E0023Z0022, D0158Z0053, D0158Z0019, E0023Z0026, E0023Z0008, D0023Z0248, D0023Z0241, D0023Z0222, D0023Z0155, B0023Z1276, C0023Z0082, D0023Z0233, B0023Z1461, D0023Z0139, D0023Z0140, D0023Z0122, B0023Z1709, E0023Z0020, E0023Z0009, E0023Z0002, D0023Z0142, E0023Z0024, E0023Z0018, E0023Z0013, E0023Z0004, C0023Z0095, C0023Z0078, E0023Z0007, E0158Z0057, E0158Z0035, B0023Z1735, B0023Z1717, B0023Z1648, B0023Z1639, B0023Z1631, C0158Z0047, C0158Z0042, B0023Z1481, B0023Z1478, B0023Z1451, B0023Z1335, B0023Z1193, B0023Z1288, B0023Z1258, B0023Z1296, B0023Z1290, B0023Z1286, B0023Z1280, B0023Z1279, B0023Z1256, B0023Z1250, B0023Z1245, B0023Z1676, B0023Z1573, B0023Z1565, B0023Z1656, B0023Z1694, D0158Z0055, B0023Z1577, B0023Z1570, B0023Z1682, B0023Z1678, B0023Z1661, B0023Z1637, D0158Z0048, D0158Z0047, E0023Z0016, E0023Z0001, D0023Z0071, D0023Z0150, D0023Z0148, D0023Z0143, B0023Z1277, D0023Z0152, D0023Z0144, D0023Z0106, D0023Z0102, B0023Z1667, B0023Z1652, B0023Z1645, B0023Z1727, B0023Z1723, B0023Z1702, E0023Z0003, D0023Z0244, D0023Z0232, C0023Z0091, D0023Z0208, B0023Z1655, D0023Z0219, D0023Z0017, D0023Z0008, C0023Z0098, C0023Z0097, C0023Z0096, C0023Z0094, C0023Z0092, B0023Z1716, B0023Z1698, B0023Z1697, B0023Z1696, B0023Z1671, B0023Z1255, B0023Z1247, B0023Z1291, B0023Z1289, B0023Z1287, B0023Z1285, B0023Z1243;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 144 units.
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