Rita Medical Systems Dispersive Electrodes packaged in an 8x10 plastic container. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Dispersive Electrodes packaged in an 8x10 plastic container.
Brand
Rita Medical Systems
Lot Codes / Batch Numbers
Lot codes affected: Y110503-1 and Y103003-2. 510k number : k031926 Contract manufacturer, Katecho, Inc, registration number 1932007
Products Sold
Lot codes affected: Y110503-1 and Y103003-2. 510k number : k031926 Contract manufacturer, Katecho, Inc, registration number 1932007
Rita Medical Systems is recalling Dispersive Electrodes packaged in an 8x10 plastic container. due to Inaccurate temperature readings may be displayed by the device, actual temperature could be 2.5-3 degrees C higher than displayed.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Inaccurate temperature readings may be displayed by the device, actual temperature could be 2.5-3 degrees C higher than displayed.
Recommended Action
Per FDA guidance
Each hospital that has been shipped the devices will receive a recall letter during the week of june 21, 2004 with materials for return shipping. Field representatives will receive notice of the recall, and will return any unused devices and document consumed devices.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026