Health product recall

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