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Patient Data Module
- Starting date:
- December 9, 2011
- Posting date:
- December 9, 2011
- 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-15110
Recalled products
- Patient Data Module
Reason
When certain monitoring systems using a patient data module are configured for auto-mode non-invasive blood pressure measurements, it is possible that the auto-mode measurements may stop automatically cycling. The problem may not be apparent to the caregiver because the last measurement remains on the screen. The caregiver can, however, view the timestamp of the last auto-mode determination to see that periodic cycling has stopped.
Affected products
A. Patient Data Module
Lot or serial number
> 100 numbers, contact manufacturer.
Model or catalog number
- PDM-XXX-XXX-XXXX
Companies
- Manufacturer
- GE Medical Systems, Information Technologies, Inc.