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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-37291
Recalled products
- Patient Data Module
Reason
The spring inside the mounting latch can become dislodged causing the patient data module (PDM) not to latch properly resulting in an unexpected loss of patient monitoring function. This may also result in the PDM falling onto 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