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Infinity Delta Patient Monitor (2017-03-31)
- Starting date:
- March 31, 2017
- Posting date:
- June 7, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-63496
Affected Products
A. Infinity Delta Patient Monitor
B. Infinity Delta XL Patient Monitor
Reason
Draeger was informed about a case in which the affected units running VF10.0 software did not generate a set low O2 alarm although the O2 level that was measured by the Draeger Scio gas measurement module was below the adjusted alarm limit. Draeger analysis revealed a failure within the VF10.0 software. Earlier software versions are not affected.
Affected products
A. Infinity Delta Patient Monitor
Lot or serial number
5396182958
6008355470
6008535267
6008537461
6008537862
6008539566
Model or catalog number
MS18597
Companies
- Manufacturer
-
Draeger Medical Systems, Inc.
3135 Quarry Road
Telford
18969
Pennsylvania
UNITED STATES
B. Infinity Delta XL Patient Monitor
Lot or serial number
Not Applicable
Model or catalog number
MS18596
Companies
- Manufacturer
-
Draeger Medical Systems, Inc.
3135 Quarry Road
Telford
18969
Pennsylvania
UNITED STATES