Philips SureSigns VM4, VM6, VM8, VS3, VSV (Vital Signs Viewer) Central Station, VS2 Vital Signs Monitor, and VS4 Vital Signs Monitor System - Vital Signs Monitor (2018-07-04)
- Starting date:
- July 4, 2018
- Posting date:
- August 31, 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-67624
Affected products
A. SureSigns VM4
B. SureSigns VM6
C. SureSigns VM8
D. SureSigns VS3
E. SureSigns VSV (Vital Signs Viewer) Central Station
F. SureSigns VS2 Vital Signs Monitor
G. SureSigns VS4 Vital Signs Monitor System - Vital Signs Monitor
Reason
Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited.
These batteries should be replaced every 3 years or upon reaching 300 charge-discharge cycles.
Although the Philips SureSigns VS & VM Monitors and View Station (VSV) can display actual information on either or both battery age and charge-discharge cycles, the existing labeling does not include full instructions on how to use this information to determine when to replace the battery.
Affected products
A. SureSigns VM4
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
863063
Companies
- Manufacturer
-
Philips Medical Systems
3000 Minuteman Road
Andover
01810
UNITED STATES
B. SureSigns VM6
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
863064
863065
Companies
- Manufacturer
-
Philips Medical Systems
3000 Minuteman Road
Andover
01810
UNITED STATES
C. SureSigns VM8
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
863066
863068
Companies
- Manufacturer
-
Philips Medical Systems
3000 Minuteman Road
Andover
01810
UNITED STATES
D. SureSigns VS3
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
863071
863072
863073
863074
Companies
- Manufacturer
-
Philips Medical Systems
3000 Minuteman Road
Andover
01810
UNITED STATES
E. SureSigns VSV (Vital Signs Viewer) Central Station
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
863067
Companies
- Manufacturer
-
Philips Medical Systems
3000 Minuteman Road
Andover
01810
UNITED STATES
F. SureSigns VS2 Vital Signs Monitor
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
863080
863081
863082
Companies
- Manufacturer
-
Philips Medical Systems
3000 Minuteman Road
Andover
01810
UNITED STATES
G. SureSigns VS4 Vital Signs Monitor System - Vital Signs Monitor
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
863283
Companies
- Manufacturer
-
Philips Medical Systems
3000 Minuteman Road
Andover
01810
UNITED STATES