RITA brand ThermoPad, Electrosurgical RF Generator and accessories Part Number: 700-102649
FDA device recall Z-0087-04 · posted 2003-11-01 · Terminated
Recall details
- Recalling firm
- Rita Medical Systems
- Reason for recall
- The product displays inaccurate temperature readings, patient skin burns can occur before getting to higher temperature reading.
- Action taken
- 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
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 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 t
- Date initiated
- 2003-10-06
- Date posted
- 2003-11-01
- Date terminated
- 2004-05-05
- Location
- Mountain View, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA THERMO PAD AND CABLE ADAPTER) (K031926) | Rita Medical Systems, Inc. | 2003-07-17 |