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Terminated

Dispersive Electrodes packaged in an 8x10 plastic container.

FDA Recall Z-1076-04 · Posted 2004-07-20

Recalling FirmRita Medical Systems
Recall StatusTerminated
Product CodeJOS
Date Initiated2004-06-16
Date Terminated2004-10-25
Product Quantity468 sets (each set consists of two pads)

Reason for Recall

Inaccurate temperature readings may be displayed by the device, actual temperature could be 2.5-3 degrees C higher than displayed.

Firm Action

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.

Root Cause

Other

Distribution Pattern

Product was shipped to 18 field representatives and 87 customers (hospitals and medical centers

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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