Fabius GS Anesthesia Machine; Gas machine for anesthesia or analgesia; Catalog Number: 8604700; Drager Medical Inc, Telf
FDA device recall Z-1315-2008 · posted 2008-07-16 · Terminated
Recall details
- Recalling firm
- Draeger Medical, Inc.
- Reason for recall
- Detachment of Component: The chassis on some machines were manufactured out of specifications. As a result, the caster may break loose from the chassis.
- Action taken
- Consignees were notified by an Urgent Medical Device Recall letter sent on 2/7/08. The letter informed users that the recalling firm will contact them to schedule appointments to inspect any potentially affected machines. The letter instructed users to continue using the machines, before the inspection, making sure to carefully follow the warnings in the instruction manual. If a caster on the machine appears unstable before the inspection is conducted, users were advised to contact the recalling firm. For additional information, contact 1-800-543-5047.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- BSZ
- Quantity affected
- 196 UNITS
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-02-05
- Date posted
- 2008-07-16
- Date terminated
- 2008-09-09
- Location
- Telford, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM (K042419) | Draeger Medical, Inc. | 2004-10-08 |