Z-1481-2018 Class I Terminated
FDA device recall Z-1481-2018 was initiated by Draeger Medical, Inc. on Mar 1, 2018 and is designated Class I. 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. The recall status is terminated (terminated Apr 16, 2019). Affected quantity: 8.
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- Mar 1, 2018
- Termination Date
- Apr 16, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8
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.
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.
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.
Code Information
Serial no: ASKM-0020 ASKM-0011 ASKL-0005 ASKL-0007 ASKL-0010 ASKM-0031 ASKM-0032 ASKM-0023
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1481-2018
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026