RF Ablation System Foot Switch, used with the EPT-1000 RF Generator, Foot Switch Model Number UPN M0048400, and in kits
FDA device recall Z-0973-2011 · posted 2011-01-27 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- Product malfunction causes inadvertent delivery of energy.
- Action taken
- The firm, Boston Scientific, sent an "URGENT: Medical Device Recall" letter dated January 14, 2009, with attached recall instructions to all customers. The letter described the product, problem, and the action to be taken by the customers. The customers were instructed to complete and return the Reply Verification Tracking Form and Obtain an RGA via fax to 408-957-6204; and return the recalled product using BSC Federal Express Number 1-809-4713-2 via second day delivery to Boston Scientific Corporation, Distribution Center, 500 Commander Shea Blvd., Quincy, MA 02171. Boston Scientific Corporation sales representatives will contact each customer. If you have any questions, please contact 408-935-4952 or email: wareb@bsci.com.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LPB
- Quantity affected
- 1044 units
- Distribution
- Worldwide distribution
- Date initiated
- 2009-07-14
- Date posted
- 2011-01-27
- Date terminated
- 2011-01-27
- Location
- San Jose, CA
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