Reported May 16, 2018 · Terminated
Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: The products are inhalation anesthesia…
Draeger Medical, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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, catalog no. 8607000
- Product UsageThe 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)
- Lot codes and dates
- Serial no
ASKF-0224ASKF-0232ASKH-0004ASKH-0007ASKH-0038ASKH-0088ASKH-0132ASKH-0133ASKJ-0007ASKJ-0178ASKJ-0179ASKJ-0184ASKJ-0205ASKJ-0220ASKJ-0224ASKK-0002ASKK-0006ASKK-0010ASKK-0011ASKK-0014ASKK-0019ASKK-0022ASKK-0023ASKK-0032ASKK-0036ASKK-0038ASKK-0044
- Serial no
- Amount recalled
- 27
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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