medical Class II Updated 2025-03-05

Pentax of America Inc recalls Pentax Medical Video Processor- Intended to be used with PEN

Recalled Product

Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c

Hazard / Issue

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 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 membranes.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: 04961333247974 Serial Numbers: B0023Z1193 B0023Z1195 B0023Z1245 B0023Z1247 B0023Z1250 B0023Z1255 B0023Z1256 B0023Z1276 B0023Z1277 B0023Z1279 B0023Z1280 B0023Z1286 B0023Z1290 B0023Z1296 B0023Z1313 B0023Z1335 B0023Z1451 B0023Z1461 B0023Z1478 B0023Z1481 B0023Z1565 B0023Z1573 B0023Z1628 B0023Z1631 B0023Z1637 B0023Z1639 B0023Z1645 B0023Z1648 B0023Z1652 B0023Z1653 B0023Z1655 B0023Z1656 B0023Z1659 B0023Z1661 B0023Z1665 B0023Z1667 B0023Z1669 B0023Z1671 B0023Z1676 B0023Z1678 B0023Z1682 B0023Z1694 B0023Z1696 B0023Z1698 B0023Z1711 B0023Z1712 B0023Z1716 B0023Z1717 B0023Z1732 C0023Z0021 C0023Z0072 C0023Z0074 C0023Z0078 C0023Z0082 C0023Z0084 C0023Z0085 C0023Z0087 C0023Z0091 C0023Z0092 C0023Z0094 C0023Z0095 C0023Z0096 C0023Z0097 D0023Z0011 D0023Z0017 D0023Z0108 D0023Z0109 D0023Z0112 D0023Z0117 D0023Z0118 D0023Z0119 D0023Z0122 D0023Z0123 D0023Z0125 D0023Z0140 D0023Z0142 D0023Z0222 D0023Z0241 D0023Z0248 D0158Z0019 D0158Z0033 D0158Z0049 D0158Z0053 E0023Z0002 E0023Z0004 E0023Z0007 E0023Z0008 E0023Z0009 E0023Z0013 E0023Z0016 E0023Z0018 E0023Z0020 E0023Z0024 E0023Z0026
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