| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01266-1 |
| Product Name/Description |
Defibrillation Electrode for Children (Leonhard Lang) used with GE defibrillators
Product Codes: 2059144-001 & 2059144-005 (DF69, 50461)
Lot numbers: 21003-0770, 21113-0777 & 21220-0771
ARTG number: 208134 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
4/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
Following an internal investigation triggered by reports in the field, it was identified that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. This could lead to a situation, in which a patient who is in a life threatening situation requiring a defibrillation can receive such therapy only with a delay or not at all. In such a situation the inability to defibrillate or a delay in doing so can as a consequence lead to the death or severe injury of the patient. This potential malfunction can occur with these electrodes after a duration of storage of about 2 years or more. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to quarantine affected lot numbers and return for replacement This action has been closed-out on 24/05/2016. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |