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