FDA Device

Fabius Trio Gas machine, anesthesia or analgesia. Catalog number 8606000. The product is used in operating rooms and ER, for patient intubation.

Hazard

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.

What You Should Do

Remedy

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.

Products

Fabius Trio Gas machine, anesthesia or analgesia. Catalog number 8606000. The product is used in operating rooms and ER, for patient intubation.
Brand
Draeger Medical, Inc.
UPC
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)

Units Affected

111 units