Food, drugs, devices › Draeger Medical, Inc.

Device recall: Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhalation anesthesia machines for u

FDA enforcement event 79773 · Class I · initiated 1 Mar 2018 · status Terminated · terminated 16 Apr 2019

DeviceVoluntary: Firm initiated4 product recordsTelford, PA

Draeger Medical, Inc. (Telford, PA) initiated this device recall on 1 Mar 2018; FDA lists 4 product records under event 79773, classified Class I.

FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 4% of the 1,074 device enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 16 Apr 2019. Initiation: voluntary: firm initiated. Draeger Medical, Inc. has 30 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Draeger Medical, Inc., Telford, PA.

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

"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."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1481-2018	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…	8	Class I	Terminated	16 May 2018
Z-1482-2018	Fabius 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…	27	Class I	Terminated	16 May 2018
Z-1483-2018	Fabius 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…	26	Class I	Terminated	16 May 2018
Z-1484-2018	Fabius 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…	1	Class I	Terminated	16 May 2018

Context

4%of 2018 device events are Class I1,074 events that year

4product records in this eventfirm median: 1

30events on this register for the firm

Other enforcement events for Draeger Medical, Inc.

Initiated	Product (first record)	Type	Class	Records
15 Oct 2024	Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended	Device	Class I	2
15 Oct 2024	Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not	Device	Class I	2
20 Mar 2024	Dr¿ger Perseus A500 Anesthesia Workstation	Device	Class I	1
12 Jul 2023	Carina Sub-Acute Care Ventilator	Device	Class I	1
12 Jun 2023	Oxylog 3000 Plus emergency and transport ventilator	Device	Class I	1
17 Apr 2023	Seattle PAP Plus, MP02260	Device	Class I	22
23 Jan 2023	NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)	Device	Class I	2
16 May 2022	Drager SafeStar 55, Catalog No. MP01790	Device	Class I	1
14 Feb 2022	Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal pa	Device	Class II	2
16 Dec 2021	Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300	Device	Class II	1

All 30 events for Draeger Medical, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "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."

What does Class I mean?

FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Where was the product distributed?

FDA's distribution pattern field reads: "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."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 16 Apr 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.