Health product recall

CARESCAPE Monitor B650 (2018-05-31)

Starting date:
May 31, 2018
Posting date:
July 19, 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-67258

Affected products

CARESCAPE Monitor B650

Reason

The following issue is being addressed by GE Healthcare File No. FMI 36127: when multiple CARESCAPE Monitor B650 units 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 had 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

CARESCAPE Monitor B650

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

CARESCAPE MONITOR B650

Companies
Manufacturer
GE Healthcare Finland OY
Kuortaneenkatu 2,
Helsinki
00510
FINLAND