FDA Medical Device Recalls (openFDA)
Rita Medical Systems: RITA brand ThermoPad, Electrosurgical RF Generator and accessories Part Number: 700-102649
- Recall number
- Z-0087-04
- Recalling firm
- Rita Medical Systems
- Product
- RITA brand ThermoPad, Electrosurgical RF Generator and accessories Part Number: 700-102649
- Status
- Terminated
- Initiated
- 2003-10-06
- Posted
- 2003-11-01
- Terminated
- 2004-05-05
- Reason
- The product displays inaccurate temperature readings, patient skin burns can occur before getting to higher temperature reading.
- Root cause
- Other
- Action
- 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.
- Quantity
- 137 + 225 units (lot Y082003)
- 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.
- Lot, serial or model codes
- Lot numbers: Y072103-3, Y082003
- 510(k) numbers
- ["K031926"]
- PMA numbers
- not on file
- Product code
- GEI
- 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