Recall Z-2478-2010 ยท BSZ Gas-Machine, Anesthesia
Draeger Medical Systems, Inc.
Fabius GS Anesthesia Machine, OR/Anesthesia, Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969 inhalation anesthesia machine for use in operating, induction and recovery rooms
| Date | Sep 23, 2010 (initiated Aug 26, 2010) |
| Status | Terminated |
| Reason | potential failures to Electri-Cord Manufacturing AC power cord |
| Root cause | Other |
| Action | Draeger Medical, Inc., sent an Urgent - Medical Device Recall letter dated August 2010 to all customers. The letter described the product, the problem, and actions to be taken by the customer. Customers were instructed to: 1) Immediately take the cord out of service if the plug has bent or cracked prongs, burned plastic, or shows signs of excessive wear. 2) Monitor the affected cords regularly and be mindful of excessive wear and tear, misuse, or abuse until the affected cord is replaced. 3) Customers were also asked to complete and return the enclosed Customer Power Cord Form via mail: |
| Quantity | up to 1973 products (GS & Tiro) |
| Distribution | Worldwide Distribution: USA and countries of Brazil, Canada, Columbia, Costa Rica, Cuba, Ecuador, Japan, Lebanon, Nicaragua, Mexico, Panama, Philippines, Saudi Arabia, Taiwan, and Venezuela |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042419 | FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM Draeger Medical, Inc., Oct 8, 2004 |