Solar 8000M/I System - Patient Monitor, Solar 9500 Information Monitor, and Dash 3000/4000/5000 Patient Monitor (2018-09-20)
- Starting date:
- September 20, 2018
- Posting date:
- October 5, 2018
- 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-67888
Affected products
A. Solar 9500 Information Monitor
B. Dash 3000 Patient Monitor
C. Dash 5000 Patient Monitor
D. Solar 8000i System - Patient Monitor
E. Solar 8000M System - Patient Monitor
F. Dash 4000 Patient Monitor
Reason
The following issue is being addressed by GE Healthcare file no. FMI 36131:
When multiple Dash or Solar Patient Monitors are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.
Loss of overall monitoring for a prolonged time may lead to a delay in detection of permanent or irreversible impairment or life-threatening changes in the condition of the patient.
Affected products
A. Solar 9500 Information Monitor
Lot or serial number
All
Model or catalog number
SOLAR 9500
Companies
- Manufacturer
-
GE Medical Systems Information Technologies, Inc.
8200 W Tower Ave
Milwaukee
53223
Wisconsin
UNITED STATES
B. Dash 3000 Patient Monitor
Lot or serial number
All
Model or catalog number
DASH3-XXXX-XXXX-XXXX
Companies
- Manufacturer
-
GE Medical Systems Information Technologies, Inc.
8200 W Tower Ave
Milwaukee
53223
Wisconsin
UNITED STATES
C. Dash 5000 Patient Monitor
Lot or serial number
All
Model or catalog number
DASH5-XXXX-XXXX-XXXX
Companies
- Manufacturer
-
GE Medical Systems Information Technologies, Inc.
8200 W Tower Ave
Milwaukee
53223
Wisconsin
UNITED STATES
D. Solar 8000i System - Patient Monitor
Lot or serial number
All
Model or catalog number
SLR8KI-XXXXXX-XXXXXX
Companies
- Manufacturer
-
GE Medical Systems Information Technologies, Inc.
8200 W Tower Ave
Milwaukee
53223
Wisconsin
UNITED STATES
E. Solar 8000M System - Patient Monitor
Lot or serial number
All
Model or catalog number
SLR80M-15=X
SLR80M-20=X
SLR80M-25=X
SLR80M-H-20=X
SLR80M-H-25=X
Companies
- Manufacturer
-
GE Medical Systems Information Technologies, Inc.
8200 W Tower Ave
Milwaukee
53223
Wisconsin
UNITED STATES
F. Dash 4000 Patient Monitor
Lot or serial number
All
Model or catalog number
DASH4-XXXX-XXXX-XXXX
Companies
- Manufacturer
-
GE Medical Systems Information Technologies, Inc.
8200 W Tower Ave
Milwaukee
53223
Wisconsin
UNITED STATES