Draeger Medical, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1481-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2). This device can also be used in MRI scanner rooms with magnets 1.5 tesla and 3 tesla at a fringe field strength of 40 mtesla or less.

Product Classification:

Class I

Date Initiated: March 1, 2018

Date Posted: May 16, 2018

Recall Number: Z-1481-2018

Event ID: 79773

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.

Status: Terminated

Product Quantity: 8

Code Information:

Serial no: ASKM-0020 ASKM-0011 ASKL-0005 ASKL-0007 ASKL-0010 ASKM-0031 ASKM-0032 ASKM-0023

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated