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Use caution Medical device recall · FDA · Published March 1, 2018

Draeger Fabius MRI Anesthesia Machine Recall: Ventilation Failure Risk

Draeger Medical recalls Fabius MRI anesthesia machines (serial numbers ASKM-0020, ASKM-0011, etc.) due to potential ventilation failure if motor position detection is disturbed or cover is damaged. This could affect patient safety during surgery.

🇺🇸 FDA recall #Z-1481-2018Medical deviceDraeger Medical ›
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Recalling firmDraeger Medical, Inc.3135 Quarry Rd · Telford, PA 18969-1042
✎ GovInfoNow plain-language explainer

Draeger Medical is recalling Fabius MRI anesthesia machines that may fail to ventilate properly if the motor position sensor is disturbed or the ventilator cover is damaged. This could lead to patient safety risks during surgery. Read more at govinfonow.com/recall/71821-draeger-fabius-mri-anesthesia-machine-recall-ventilation-failure-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/71821-draeger-fabius-mri-anesthesia-machine-recall-ventilation-failure-risk · Updated August 27, 2026 · FDA enforcement record: FDA #Z-1481-2018

Cite this page

“Draeger Fabius MRI Anesthesia Machine Recall: Ventilation Failure Risk.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/71821-draeger-fabius-mri-anesthesia-machine-recall-ventilation-failure-risk. Based on FDA recall #Z-1481-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1481-2018%22&limit=1).

The FDA announced on March 1, 2018, that Draeger Medical, Inc. is recalling Fabius MRI anesthesia machines due to potential ventilator failure. The agency classified the recall as Class I.

How to tell if you have it

  • Brand: Draeger Medical
  • Product: Fabius MRI, anesthesia machine
  • Catalog no.: 8607300
  • Serial nos.: ASKM-0020, ASKM-0011, ASKL-0005, ASKL-0007, ASKL-0010, ASKM-0031, ASKM-0032, ASKM-0023
  • Quantity: 8 units

The hazard

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.

Context

GovInfoNow's records show Draeger Medical, Inc. has had 16 other recalls on record since April 26, 2018. Other recent recalls of similar products include the Draeger Atlan A300XL Anesthesia Workstation Recall (Oct. 15, 2024), the Draeger Atlan A350XL Anesthesia Workstation Recall (Oct. 15, 2024), and the Draeger Perseus A5 recall (March 20, 2024).

How to tell if you have this one

Check for serial numbers: ASKM-0020, ASKM-0011, ASKL-0005, ASKL-0007, ASKL-0010, ASKM-0031, ASKM-0032, ASKM-0023. These machines are used in operating rooms for inhalation anesthesia during surgery.

  • Brand
    Draeger Medical
  • Category
    Medical device
FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class I
  • Status
    Terminated
  • 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.
Recall numberProduct, codes & lotsQuantity
Z-1481-2018Fabius 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.; Serial no: ASKM-0020 ASKM-0011 ASKL-0005 ASKL-0007 ASKL-0010 ASKM-0031 ASKM-0032 ASKM-00238
Z-1482-2018Fabius GS Premium, anesthesia machine, catalog no. 8607000 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).; Serial no: ASKF-0224 ASKF-0232 ASKH-0004 ASKH-0007 ASKH-0038 ASKH-0088 ASKH-0132 ASKH-0133 ASKJ-0007 ASKJ-0178 ASKJ-0179 ASKJ-0184 ASKJ-0205 ASKJ-0220 ASKJ-0224 ASKK-0002 ASKK-0006 ASKK-0010 ASKK-0011 ASKK-0014 ASKK-0019 ASKK-0022 ASKK-0023 ASKK-0032 ASKK-0036 ASKK-0038 ASKK-004427
Z-1483-2018Fabius Tiro, anesthesia machine, catalog no. 8606000 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).; Serial no: ASKJ-0195 ASKK-0079 ASKF-0226 ASKF-0227 ASKF-0228 ASKF-0229 ASKF-0230 ASKH-0086 ASKH-0071 ASKJ-0177 ASKK-0020 ASKK-0021 ASKH-0053 ASKH-0054 ASKH-0055 ASKH-0056 ASKH-0057 ASKH-0067 ASKH-0068 ASKH-0063 ASKH-0065 ASKH-0064 ASKH-0130 ASKH-0131 ASKJ-0173 ASKH-003126
Z-1484-2018Fabius Tiro M, anesthesia machine, catalog no. 8608400 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).; Serial no. ASKK-00011
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Number

    Look for the serial numbers listed: ASKM-0020, ASKM-0011, ASKL-0005, ASKL-0007, ASKL-0010, ASKM-0031, ASKM-0032, ASKM-0023.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 21 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: nationwideLAMississippi: named in the noticeMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFLPuerto Rico: named in the noticePR

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Colorado, Idaho, Illinois, Kansas, Massachusetts, Michigan, Mississippi, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 14 months after the firm started it.

1. Firm started the recall: Mar 1, 201812. FDA classified it Class I: May 7, 201823. Published in FDA’s Enforcement Report: May 16, 201834. FDA terminated the recall: Apr 16, 2019420182019
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1481-2018 (March 1, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1481-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA