CanadaCARESCAPE B450 patient monitors (Model/catalogue numbers 2095800-001, 2107633-001, 5805686 and software 2068086-451) are affected; affected units are identified by serial or lot numbers of more than 10 numbers—contact the manufacturer for specifics. They were recalled because of a potential loss of monitoring on CARESCAPE B450, CARESCAPE ONE, B1x5M/B1x5P VSP3.0, B1x5M/B1x5P VSP4.0 and portrait vital signs monitors when powered by certain batteries. Contact the manufacturer if you require additional information.
What's being recalled
Companies: GE Healthcare Finland Oy, Kuortaneenkatu 2, Helsinki, Finland, 00510.
How to identify it
Affected products: CARESCAPE B450; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 2095800-001
Affected products: CARESCAPE B450; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 2107633-001
Affected products: CARESCAPE B450; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 5805686
Affected products: CARESCAPE Monitor B450 - Software; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 2068086-451
The hazard
Potential loss of monitoring on CARESCAPE B450, CARESCAPE ONE, B1x5M/B1x5P VSP3.0, B1x5M/B1x5P VSP4.0 patient monitors and portrait vital signs monitor when powered by certain batteries.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States