| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00931-1 |
| Product Name/Description |
The Insides Driver (a component of The Insides System PS006 and The Insides System Patient Education Model (Part number: MK-1R001))
Driver:
Part number: PS001
Lot numbers: LOT0000212, LOT0000227 & LOT0000225
Serial numbers: 01000250, 01000245 & 01000266 & 01000262
Insides System and Patient Education Model:
Part numbers: PS006 & MK-1R001
Lot numbers: LOT0000215 & LOT0000236
Serial numbers: 0600007D, 06000079 & 0600008D
Supplied through the Special Access Scheme (SAS) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/10/2023 |
| Responsible Entity |
|
| Reason/Issue |
A single unit of The Insides Driver has overheated, caught fire, and exploded while being recharged from a low battery state. If the device is to explode there is a risk of burns and smoke inhalation to the patient, care givers or healthcare professionals.
This recall does not affect any other lots of The Insides Driver (PS001) contained in any other lots of The Insides System (PS006) or The Insides System Patient Education Model (Part number: MK-1R001) or any other The Insides Company products. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to quarantine affected stock to prevent further use and contact Optimed Technologies to arrange for a replacement. |
| Contact Information |
02 9052 7888 - Optimed Technologies. |