Olympus Endoscopic Electrosurgical Unit working elements, model numbers WA22066A and WA22067A. Working element for endos
FDA device recall Z-0828-2012 · posted 2012-01-20 · Terminated
Recall details
- Recalling firm
- Olympus America Inc.
- Reason for recall
- Less than optimal thickness in the plastic housing holding the electrode in the Olympus Working Elements
- Action taken
- Olympus America Inc. sent an "URGENT: MEDICAL DEVICE WITHDRAWAL" letter dated December 27, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to inspect their inventory for the affected product and discontinue use of any affected product discovered. Customers should contact the Gyrus ACMI Customer Service Department at 1-888-524-7266 for credit or replacement of the product. Additionally, an Olympus Working Elements Withdrawal form was enclosed for customers to complete and fax to 484-896-7128. Contact the firm at 484-896-5688 for questions regarding this notice.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- KNS
- Distribution
- Nationwide Distribution-including Washington, D.C. and the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MI, MN, MO, MT, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, TN,
- Date initiated
- 2011-12-27
- Date posted
- 2012-01-20
- Date terminated
- 2013-12-21
- Location
- Center Valley, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT (K030194) | The Olympus Optical Co. | 2003-03-24 |