Channel Medsystems, Inc.: Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The Cerene Cryotherapy Device is

Hazard

Error code 003 was not listed in certain rows of the Device Instructions for Use Troubleshooting section (i.e., Table 22. Summary of LCD Messages and Error Codes).

Details from the source

Reason for recall: Error code 003 was not listed in certain rows of the Device Instructions for Use Troubleshooting section (i.e., Table 22. Summary of LCD Messages and Error Codes). Distribution: Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina Quantity: 1772 Lot/code info: Lot Code: Model No: FGS-7000 UDI-DI: 00850008595035 Lot Numbers: All non-expired lots manufactured through February 2024 101635693, 101635694, 101635695, 101635696, 102211255, 102211256, 102211257, 102211258, 102887363, 102887364, 103151029, 103151030, 103151031, 103151032, 103489753, 103489754, 103489755, 103489756, 103489757, 103925402, 104008714, 104008715, 104521903, 104521904, 104521905, 104521906, 104521907, 104808352, 104808353, 105418198, 105733204, 105733205

UPC codes

00850008595035

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.