FDA Medical Device Recalls (openFDA)
Rita Medical Systems: Dispersive Electrodes packaged in an 8x10 plastic container.
- Recall number
- Z-1076-04
- Recalling firm
- Rita Medical Systems
- Product
- Dispersive Electrodes packaged in an 8x10 plastic container.
- Status
- Terminated
- Initiated
- 2004-06-16
- Posted
- 2004-07-20
- Terminated
- 2004-10-25
- Reason
- Inaccurate temperature readings may be displayed by the device, actual temperature could be 2.5-3 degrees C higher than displayed.
- 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
- 468 sets (each set consists of two pads)
- Distribution
- Product was shipped to 18 field representatives and 87 customers (hospitals and medical centers
- Lot, serial or model codes
- Lot codes affected: Y110503-1 and Y103003-2. 510k number : k031926 Contract manufacturer, Katecho, Inc, registration number 1932007
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JOS
- Firm FEI
- 1000523114
- Firm city
- Mountain View
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28