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Dash and Tram 451 Patient Monitors and Patient Data Module (2013-02-26)
- Starting date:
- February 26, 2013
- Posting date:
- October 22, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-55470
Affected Products
- A. Dash 3000 Patient Monitor
- B. Dash 5000 Patient Monitor
- C. Patient Data Module
- D. Patient Data Module
- E. Dash 4000 Patient Monitor
Reason
ECG and respiration signal noise caused by Dash, PDM and/or Tram ECG cable connector movement may result in reduced ECG, respiration and arrhythmia detection performance.
Affected products
A. Dash 3000 Patient Monitor
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
DASH3-XXXX-XXXX-XXXX
Companies
- Manufacturer
-
GE Medical Systems Information Technologies, Inc.
8200 West Tower Avenue
Milwaukee
Wisconsin
UNITED STATES
B. Dash 5000 Patient Monitor
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
DASH5-XXXX-XXXX-XXXX
Companies
- Manufacturer
-
GE Medical Systems Information Technologies, Inc.
8200 West Tower Avenue
Milwaukee
Wisconsin
UNITED STATES
C. Tram 451 Patient Monitor
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
T451=A
Companies
- Manufacturer
-
GE Medical Systems Information Technologies, Inc.
8200 West Tower Avenue
Milwaukee
Wisconsin
UNITED STATES
D. Patient Data Module
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
PDM-XXX-XXX-XXXX
Companies
- Manufacturer
-
GE Medical Systems Information Technologies, Inc.
8200 West Tower Avenue
Milwaukee
Wisconsin
UNITED STATES
E. Moniteur patient Dash 4000
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
DASH4-XXXX-XXXX-XXXX
Companies
- Manufacturer
-
GE Medical Systems Information Technologies, Inc.
8200 West Tower Avenue
Milwaukee
Wisconsin
UNITED STATES