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