FDA Medical Device Recalls (openFDA)
Draeger Medical, Inc.: Fabius Trio Gas machine, anesthesia or analgesia. Catalog number 8606000. The product is used in operating rooms and ER, for patient intubation.
- Recall number
- Z-2338-2008
- Recalling firm
- Draeger Medical, Inc.
- Product
- Fabius Trio Gas machine, anesthesia or analgesia. Catalog number 8606000. The product is used in operating rooms and ER, for patient intubation.
- Status
- Terminated
- Initiated
- 2008-07-07
- Posted
- 2008-09-23
- Terminated
- 2010-03-08
- Reason
- The parent company became aware of instances where the lower side rail of the frame of the machine broke inwards when being moved across a threshold; resulting in the machine being unstable.
- Root cause
- Process control
- Action
- The firm has issued a MEDICAL DEVICE RECALL letter dated 7/7/08 to its customers via certified mail. The letter informs them of the problem and to exercise care when using the device until it has been retrofitted. Contact Drager Medical at 1-800-543-5047, #4 for assistance.
- Quantity
- 111 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Serial numbers: ARYA-xxxx, ARYB-xxxx, ARYC-xxxx, ARYD-xxxx, ARYE-xxxx, ARYF-xxxx, ARYH-xxxx, ARYJ-xxxx, ARYK-xxxx, ARYL-xxxx, ARYM-xxxx,ARYN-xxxx, ARZA-xxxx ARZB-xxxx (where xxxx represents any 4 digit number)
- 510(k) numbers
- ["K042419"]
- PMA numbers
- not on file
- Product code
- BSZ
- Firm FEI
- 2517967
- Firm city
- Telford
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28