Health product recall

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