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Patient Data Module (2013-11-11)
- Starting date:
- November 11, 2013
- Posting date:
- January 6, 2014
- 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-37295
Recalled products
- Patient Data Module
Reason
Fluid can pass through the seals in the top cover and come into contact with energized contacts in the circuit board. This can result in heat buildup, smoke, and discoloration. This heat buildup could potentially result in thermal injury to a patient or caregiver.
Affected products
A. Patient Data Module
Lot or serial number
- Not applicable
Model or catalog number
- PDM-XXX-XXX-XXXX
Companies
- Manufacturer
-
GE Medical Systems Information Technologies, Inc.
8200 West Tower Avenue
Milwaukee
53223
Wisconsin
UNITED STATES