Z-1076-04

Dispersive Electrodes packaged in an 8x10 plastic container

Name: Z-1076-04 Dispersive Electrodes packaged in an 8x10 plastic container
Creator: Rita Medical Systems
Published: 2004-06-16
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2004-06-16 / Terminated

FDA source

Rita Medical Systems began a recall of Dispersive Electrodes packaged in an 8x10 plastic container on 2004-06-16. The reason FDA records is "Inaccurate temperature readings may be displayed by the device, actual temperature could be 2.5-3 degrees C higher than displayed". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1076-04
Status: Terminated
Initiated: 2004-06-16
Posted: 2004-07-20
Terminated: 2004-10-25
Recalling firm: Boston Scientific Corporation
Product: Dispersive Electrodes packaged in an 8x10 plastic container.
Product code: JOS Electrode, Electrosurgical
Reason for recall: Inaccurate temperature readings may be displayed by the device, actual temperature could be 2.5-3 degrees C higher than displayed.
FDA root cause: Other
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.
Quantity in commerce: 468 sets (each set consists of two pads)
Distribution: Product was shipped to 18 field representatives and 87 customers (hospitals and medical centers
Product codes and lots: Lot codes affected: Y110503-1 and Y103003-2. 510k number : k031926 Contract manufacturer, Katecho, Inc, registration number 1932007

Product code JOS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)