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
- ECG Leads and Cables
- 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