RITA brand ThermoPad, Electrosurgical RF Generator and accessories Part Number: 700-102649
FDA Recall Z-0087-04 · Posted 2003-11-01
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Recalling FirmRita Medical Systems
Recall StatusTerminated
Product CodeGEI
Date Initiated2003-10-06
Date Terminated2004-05-05
Product Quantity137 + 225 units (lot Y082003)
Reason for Recall
The product displays inaccurate temperature readings, patient skin burns can occur before getting to higher temperature reading.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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