Health product recall

CARESCAPE Monitors B450, B650, and B850 (2018-09-12)

Starting date:
September 12, 2018
Posting date:
April 29, 2019
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-69784

Last updated: 2019-04-30

Affected Products

A. CARESCAPE Monitor B850 System - C1 CPU
B. CARESCAPE Monitor B450 - Main Unit
C. CARESCAPE Monitor B650
D. CARESCAPE Monitor B850 System

Reason

The following issue is being addressed by GE Healthcare File No. FMI 36127: when multiple CARESCAPE Monitor B450, B650, or B850 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.
When a network overload occurs for a prolonged time, it is also possible that a CARESCAPE Monitor B850 is not rebooting but loses connection with the patient data module (PDM) and a message ""PDM module removed"" is displayed.
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. CARESCAPE Monitor B850 System - C1 CPU

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

2020913-004

Companies
Manufacturer

GE Healthcare Finland OY

Kuortaneenkatu 2,

Helsinki

00510

FINLAND

B. CARESCAPE Monitor B450 - Main Unit

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

CARESCAPE Monitor B450

Companies
Manufacturer

GE Healthcare Finland OY

Kuortaneenkatu 2,

Helsinki

00510

FINLAND

C. 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

D. CARESCAPE Monitor B850 System

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

2020913-002

Companies
Manufacturer

GE Healthcare Finland OY

Kuortaneenkatu 2,

Helsinki

00510

FINLAND