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FABIUS Tiro Anesthesia System, GS Premium System and MRI (2017-11-01)
- Starting date:
- November 1, 2017
- Posting date:
- November 15, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals, Healthcare Professionals
- Identification number:
- RA-65122
Affected products
- FABIUS TIRO ANESTHESIA SYSTEM
- FABIUS GS PREMIUM SYSTEM
- FABIUS MRI
Reason
Draeger has become aware of information suggesting that the use of the Auxiliary Common Gas Outlet (ACGO) at anesthesia workstations of different manufacturers was not performed as described in the instructions for use of the relevant manufacturer, and not according to published safety guidelines (pre-use checklist) from various anesthesia societies.
Affected products
-
FABIUS TIRO ANESTHESIA SYSTEM
Lot or serial number
ASDH-0190
Model or catalog number
8606000
Companies
- Manufacturer
-
DRAEGERWERK AG & CO
MOISLINGER ALLEE 53-55
LUBECK
23542
GERMANY
B. FABIUS GS PREMIUM SYSTEM
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
8607000
Companies
- Manufacturer
-
DRAEGERWERK AG & CO
MOISLINGER ALLEE 53-55
LUBECK
23542
GERMANY
C.FABIUS MRI
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
8607300
Companies
- Manufacturer
-
DRAEGERWERK AG & CO
MOISLINGER ALLEE 53-55
LUBECK
23542
GERMANY