VITAL SIGNS MONITOR 6000 SERIES (6300 BASIC) (2021-08-06)
- Starting date:
- August 6, 2021
- Posting date:
- August 19, 2021
- 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-76261
Last updated: 2021-08-19
Affected Products
- VITAL SIGNS MONITOR 6000 SERIES (6300 BASIC)
- VITAL SIGNS MONITOR 6000 SERIES (6500 STANDARD)
- VITAL SIGNS MONITOR 6000 SERIES (6500 WIRELESS)
- CONNEX INTEGRATED WALL SYSTEM (CIWS) (840000 STANDARD)
- CONNEX INTEGRATED WALL SYSTEM (CIWS) (850000 WIRELESS)
- VITAL SIGNS MONITOR 6000 SERIES (CVSM 6700)
- VITAL SIGNS MONITOR 6000 SERIES (CVSM 6800)
- CONNEX SPOT MONITOR (7100 SERIES)
- CONNEX SPOT MONITOR (7300 SERIES)
- CONNEX SPOT MONITOR (7400 SERIES)
- CONNEX SPOT MONITOR (7500 SERIES)
- BRAUN THERMOSCAN PRO 6000
- BRAUN PRO 6000
Reason
Hillrom has become aware of customer complaint alleging that the speculum tip on the Braun PRO6000 was overheating. An investigation into the root cause of the speculum tip overheating determined that fluid ingress is causing the sensor to behave inconsistently, which ultimately does not allow the built-in safety mitigation to work correctly.
Affected products
A. VITAL SIGNS MONITOR 6000 SERIES (6300 BASIC)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
63MXPE-B
63MXXE-B
63NXPE-B
63NXXE-B
Companies
- Manufacturer
-
Welch Allyn Inc.
4341 State Street Road
Skaneateles Falls
13153-0220
New York
UNITED STATES
B. VITAL SIGNS MONITOR 6000 SERIES (6500 STANDARD)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
64MTPE-B
64MTXE-B
64MXPE-B
64MXXE-B
64NTPE-B
64NTXE-B
64NXPE-B
64NXXE-B
64XXXE-B
Companies
- Manufacturer
-
Welch Allyn Inc.
4341 State Street Road
Skaneateles Falls
13153-0220
New York
UNITED STATES
C. VITAL SIGNS MONITOR 6000 SERIES (6500 WIRELESS)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
65MTXE-B
65MXXE-B
65NXPE-B
65XXXE-B
Companies
- Manufacturer
-
Welch Allyn Inc.
4341 State Street Road
Skaneateles Falls
13153-0220
New York
UNITED STATES
D. CONNEX INTEGRATED WALL SYSTEM (CIWS) (840000 STANDARD)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
84MXVEC-B
84NTVEC-B
84NTVEP-B
84NXVEC-B
84NXVEP-B
84XXVEC-B
84XXVEP-B
Companies
- Manufacturer
-
Welch Allyn Inc.
4341 State Street Road
Skaneateles Falls
13153-0220
New York
UNITED STATES
E. CONNEX INTEGRATED WALL SYSTEM (CIWS) (850000 WIRELESS)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
85MTVEC-B
85MXVEC-B
85MXVEP-B
85NTVEP-B
Companies
- Manufacturer
-
Welch Allyn Inc.
4341 State Street Road
Skaneateles Falls
13153-0220
New York
UNITED STATES
F. VITAL SIGNS MONITOR 6000 SERIES (CVSM 6700)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
67MCEP-B
67MXEP-B
67MXEX-B
67MXTP-B-ECG3A
67NXEP-B
67NXEX-B
67NXTP-B-ECG3A
Companies
- Manufacturer
-
Welch Allyn Inc.
4341 State Street Road
Skaneateles Falls
13153-0220
New York
UNITED STATES
G. VITAL SIGNS MONITOR 6000 SERIES (CVSM 6800)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
68MXEP-B
68MXEX-B
68NCEX-B
68NCEY-B
68NXEP-B
68NXEX-B
Companies
- Manufacturer
-
Welch Allyn Inc.
4341 State Street Road
Skaneateles Falls
13153-0220
New York
UNITED STATES
H. CONNEX SPOT MONITOR (7100 SERIES)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
71WE-B
71XE-B
Companies
- Manufacturer
-
Welch Allyn Inc.
4341 State Street Road
Skaneateles Falls
13153-0220
New York
UNITED STATES
I. CONNEX SPOT MONITOR (7300 SERIES)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
73CE-B
73ME-B
73WE-B
73XE-B
Companies
- Manufacturer
-
Welch Allyn Inc.
4341 State Street Road
Skaneateles Falls
13153-0220
New York
UNITED STATES
J. CONNEX SPOT MONITOR (7400 SERIES)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
74CE-B
74ME-B
Companies
- Manufacturer
-
Welch Allyn Inc.
4341 State Street Road
Skaneateles Falls
13153-0220
New York
UNITED STATES
K. CONNEX SPOT MONITOR (7500 SERIES)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
75CE-B
75ME-B
75WE-B
Companies
- Manufacturer
-
Welch Allyn Inc.
4341 State Street Road
Skaneateles Falls
13153-0220
New York
UNITED STATES
L. BRAUN THERMOSCAN PRO 6000
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
06000-200
06000-300
Companies
- Manufacturer
-
Welch Allyn Inc.
4341 State Street Road
Skaneateles Falls
13153-0220
New York
UNITED STATES
M. BRAUN PRO 6000
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
06000-900
Companies
- Manufacturer
-
Welch Allyn Inc.
4341 State Street Road
Skaneateles Falls
13153-0220
New York
UNITED STATES