RITA brand ThermoPad, Electrosurgical RF Generator and… recallZ-0087-04 · Rita Medical Systems · initiated Oct 6, 2003
Terminated All recalls posted in November 2003
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Rita Medical Systems or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The product displays inaccurate temperature readings, patient skin burns can occur before getting to higher temperature reading.
FDA root cause category: Other
What the company is doing
On 10/6/03, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected devices and providing instructions on the recall.
Recall details
- Recall number
- Z-0087-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 6, 2003
- Posted by the FDA
- Nov 1, 2003
- Recalling firm
- Rita Medical Systems
- Quantity
- 137 + 225 units (lot Y082003)
- Product code
- GEI
- FDA submissions
- K031926
- Distribution
- Product was released for distribution to 66 consignees in US. The product received nationwide distribution. The recall was appropriately extended to the user level; i.e., the hospitals that received the recalled product. There were no shipments to foreign or Canadian distribution, however, it includes one military distribution: Wilford Hall Medical Center, 2200 Berquist Dr., 31, Lackland AFB, TX 78236.
Product description
RITA brand ThermoPad, Electrosurgical RF Generator and accessories Part Number: 700-102649
Code information (models, lots, serial numbers)
Lot numbers: Y072103-3, Y082003
Other devices under the same FDA submission
1 device cleared under K031926 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- RITA 700102649Angiodynamics, Inc. · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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