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TRILOGY (100) VENTILATOR SYSTEMS (2016-01-14)
- Starting date:
- January 14, 2016
- Posting date:
- February 8, 2016
- 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-57022
Affected Products
A. TRILOGY 100 VENTILATOR-CANADA
B. TRILOGY 100 VENTILATOR-INTERNATIONAL
C. TRILOGY 202, INTERNATIONAL
D. TRILOGY 202, DOMESTIC
E. TRILOGY 200, CANADA
Reason
Trilogy Ventilators with software versions 13.2.04, 13.2.05, 14.0.00 or 14.1.01 are susceptible to an inadvertent change between prescriptions. This may occur under a particular set of operating conditions and after a specific sequence of key presses without requiring confirmation of the change by the user. Affected devices continue to accurately display the active prescription in the upper left hand corner of the display. As this prescription change was unintended and no confirmation was required, the user may be unaware of this change.
Affected products
A. TRILOGY 100 VENTILATOR-CANADA
Lot or serial number
All
Model or catalog number
- CA1054096
- R1054260
Companies
- Manufacturer
-
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES
B. TRILOGY 100 VENTILATOR-INTERNATIONAL
Lot or serial number
All
Model or catalog number
1054096
U1054096
Companies
- Manufacturer
-
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES
C. TRILOGY 202, INTERNATIONAL
Lot or serial number
All
Model or catalog number
1040000
CA1040000
Companies
- Manufacturer
-
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES
D. TRILOGY 202, DOMESTIC
Lot or serial number
All
Model or catalog number
1040007
Companies
- Manufacturer
-
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES
E. TRILOGY 200, CANADA
Lot or serial number
All
Model or catalog number
CA1032800
Companies
- Manufacturer
-
Respironics Inc.
1001 Murray Ridge Lane
Murraysville
15668
Pennsylvania
UNITED STATES