Health product recall

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