Dispersive Electrodes packaged in an 8x10 plastic container.
FDA device recall Z-1076-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Rita Medical Systems
- Reason for recall
- Inaccurate temperature readings may be displayed by the device, actual temperature could be 2.5-3 degrees C higher than displayed.
- Action taken
- 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
- Status
- Terminated
- Product code
- JOS
- Quantity affected
- 468 sets (each set consists of two pads)
- Distribution
- Product was shipped to 18 field representatives and 87 customers (hospitals and medical centers
- Date initiated
- 2004-06-16
- Date posted
- 2004-07-20
- Date terminated
- 2004-10-25
- Location
- Mountain View, CA
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