Reported Jun 27, 2018 · Terminated
Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inhalation anesthesia machines for use in…
Draeger Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Draeger Medical, Inc. · 3135 Quarry Rd · Telford, PA · 18969-1042
Is this the product you have?
- Fabius GS Premium Anesthesia Machine; Cat. no. 8607000
- Product UsageInhalation 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 machines are equipped with a compact breathing system; providing fresh gas decoupling, PEEP, and pressure limitation. The following
- ventilation options are availableVolume Controlled Ventilation Pressure Controlled Ventilation Pressure Support (Optional) SIMV/PS (Optional) Manual Ventilation Spontaneous Breathing 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). As per IEC 60601-2-13 (Anesthetic Workstations and their Modules-Particular Requirements), additional monitoring of the concentrations of CO2 and anesthetic agent is required when the machine is in use
- IEC 60601-2-132003 requires that a manual ventilation bag must be available for emergency use. Fresh gas enrichment is provided by the Dr¿ger Vapor anesthetic vaporizer. Fabius MRI 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
- Lot codes and dates
62 of 62 codes
ASKM-0102ASKM-0220ASKM-0103ASKM-0221ASKM-0124ASKM-0222ASKM-0125ASKM-0223ASKM-0129ASKM-0224ASKM-0132ASKM-0229ASKM-0133ASKN-0061ASKM-0134ASKN-0090ASKM-0135ASLA-0035ASKM-0136ASLA-0046ASKM-0137ASLA-0047ASKM-0138ASLA-0048ASKM-0139ASLA-0049ASKM-0189ASLA-0050ASKM-0190ASLA-0053ASKM-0191ASLA-0070ASKM-0192ASLA-0071ASKM-0193ASLA-0072ASKM-0194ASLA-0073ASKM-0195ASLA-0074ASKM-0198ASLA-0075ASKM-0199ASLA-0129ASKM-0200ASLA-0131ASKM-0201ASLA-0133ASKM-0202ASLA-0140ASKM-0204ASLA-0141ASKM-0205ASLA-0159ASKM-0207ASLA-0199ASKM-0208ASLA-0200ASKM-0215ASLA-0201
- Amount recalled
- 62
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Draeger Medical, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.