Olympus Electrosurgical Unit. The Olympus Electrosurgical Unit (ESG-100) is used in conjunction with cutting and coagula
FDA device recall Z-0747-2012 · posted 2012-01-13 · Terminated
Recall details
- Recalling firm
- Olympus America Inc.
- Reason for recall
- Investigations of customer complaints revealed a counterfeit capacitor was used in the manufacture of some lots of the ESG-100.
- Action taken
- Olympus America Inc. sent an URGENT: MEDICAL DEVICE CORRECTION ACTION" letter dated November 28, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of the affected product. A questionnaire was attached to the letter for customers to complete and return via fax at 484-896-7128. Contact the firm at 484-896-5000 for questions regarding this notice.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 245
- Distribution
- Nationwide Distribution.
- Date initiated
- 2011-11-28
- Date posted
- 2012-01-13
- Date terminated
- 2013-03-01
- Location
- Center Valley, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167 (K073207) | Celon AG Medical Instruments | 2008-05-08 |