Z-0087-04

RITA brand ThermoPad, Electrosurgical RF Generator and accessories Part Number: 700-102649

Name: Z-0087-04 RITA brand ThermoPad, Electrosurgical RF Generator and accessories Part Number: 700-102649
Creator: Rita Medical Systems
Published: 2003-10-06
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2003-10-06 / Terminated

FDA source

Rita Medical Systems began a recall of RITA brand ThermoPad, Electrosurgical RF Generator and accessories Part Number: 700-102649 on 2003-10-06. The reason FDA records is "The product displays inaccurate temperature readings, patient skin burns can occur before getting to higher temperature reading". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0087-04
Status: Terminated
Initiated: 2003-10-06
Posted: 2003-11-01
Terminated: 2004-05-05
Recalling firm: Boston Scientific Corporation
Product: RITA brand ThermoPad, Electrosurgical RF Generator and accessories Part Number: 700-102649
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: The product displays inaccurate temperature readings, patient skin burns can occur before getting to higher temperature reading.
FDA 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 in commerce: 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.
Product codes and lots: Lot numbers: Y072103-3, Y082003

Product code GEI

K031926Class IIRita Model 1500X Electrosurgical RF Generator and Accessories (E.g., Rita Thermo Pad and Cable Adapter)Rita Medical Systems, Inc. / cleared 2003-07-17

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)