Altrus Energy Source REF 60-9500-120 Tissue Fusion Energy Source ConMed Corporation 525 French Rd, Utica, NY 13502, MDSS
FDA device recall Z-1678-2012 · posted 2012-05-29 · Terminated
Recall details
- Recalling firm
- ConMed Electrosurgery
- Reason for recall
- An investigation of the ConMed Electrosurgery Altrus Energy Source revealed that the device could have been calibrated incorrectly resulting in error messages or delays in surgery.
- Action taken
- ConMed Electrosurgery sent an "URGENT: MEDICAL DEVICE" letter dated May 2, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to review their inventory for the affected product and to complete and return a Business Reply Form to the firm via fax to 303-699-9854.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 122 units
- Distribution
- Nationwide Distribution and the country of Canada.
- Date initiated
- 2012-05-07
- Date posted
- 2012-05-29
- Date terminated
- 2012-06-19
- Location
- Centennial, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM (K101534) | Conmedcorp | 2010-11-24 |