Health product recall

ECG Leads and Cables, ECG Trunk Cables (2019-05-15)

Starting date:
May 15, 2019
Posting date:
May 31, 2019
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-70067



Last updated: 2019-05-31

Affected Products

  1. ECG Leads and Cables
  2. ECG Trunk Cables

Reason

ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patient's rhythm. If this issue occurs during a defibrillation event, it may not be noticeable to the caregiver and could contribute to an adverse patient outcome.

Affected products

A. ECG Leads and Cables

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 106391-005
  • 2106381-001
  • 2106381-002
  • 2106381-005
  • 2106383-002
  • 2106383-005
  • 2106385-001
  • 2106389-001
  • 2106389-002
  • 2106389-005
  • 2106390-001
  • 2106390-002
  • 2106391-001
  • 2106391-002
  • 2106393-001
Companies
Manufacturer

GE Healthcare Finland OY

Kuortaneenkatu 2,

Helsinki

00510

FINLAND


B. ECG Trunk Cables

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 2106305-001
  • 2106305-002
  • 2106306-001
  • 2106306-002
  • 2106308-001
  • 2106308-002
  • 2106310-001
  • 2106311-001
  • 2106381-001
  • 2106381-002
  • 2106381-005
  • 2106383-002
  • 2106383-005
  • 2106385-001
  • 2106389-001
  • 2106389-002
  • 2106389-005
  • 2106390-001
  • 2106390-002,
  • 2106391-001
  • 2106391-002
  • 2106391-005
  • 2106393-001
Companies
Manufacturer

GE Healthcare Finland OY

Kuortaneenkatu 2,

Helsinki

00510

FINLAND