Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The products are inhalation anesthesia machines for
FDA device recall Z-1483-2018 · posted 2018-05-08 · Terminated
Recall details
- Recalling firm
- Draeger Medical, Inc.
- Reason for recall
- The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.
- Action taken
- On March 1, 2018, the recalling firm notified affected customers via an Urgent Medical Device Recall letter. The recalling firm stated that customers would receive replacement motors for potentially affected devices. Until the replacement occurred, customers were instructed to continue to operate their devices with the usual attention and make sure that a manual resuscitator for emergency ventilation is kept ready according to the instructions for use. Customers were also supplied with a reply card to indicate that they had received the notification. Customers with questions about the letter were directed to call Michael Kelhart between 8AM-4:30PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349). Questions regarding the operation and/or servicing of the Draeger Fabius anesthesia machine were directed to DraegerService Technical Support between the hours of 8:00 AM 8:00 PM EST at 1-800-437-2437 (press 4 at the prompt then 4 again).
- Root cause
- Process control
- Status
- Terminated
- Product code
- BSZ
- Quantity affected
- 26
- Distribution
- US Nationwide Distribution to accounts in 21 states: AZ, CA, CO, ID, IL, KS, MA, MI, MS, NC, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI; and PR.
- Date initiated
- 2018-03-01
- Date posted
- 2018-05-08
- Date terminated
- 2019-04-16
- 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 |