Patient Data Module (PDM) (2020-05-21)
- Starting date:
- May 21, 2020
- Posting date:
- June 12, 2020
- 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-73313
Last updated: 2020-06-12
Affected Products
Patient Data Module (PDM)
Reason
While using Carescape PDM, the accompanying monitor may display incorrect ECG data if pace detection is turned on and an AED is used to perform defibrillation.
Affected products
Patient Data Module (PDM)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
2042084-001
Companies
- Manufacturer
-
GE Medical Systems Information Technologies, Inc.
8200 W Tower Ave
Milwaukee
53223
Wisconsin
UNITED STATES