| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00626-1 |
| Product Name/Description |
Spectra Optia Apheresis Systems
Serial Number Range: 1P04028 to 1P04392
ARTG Number: 130529 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/05/2017 |
| Responsible Entity |
|
| Reason/Issue |
During routine testing by the manufacturer, a device that is similar to the Spectra Optia system demonstrated a non-recoverable power failure. A subsequent investigation determined that a power filter cable, a component used in the internal electrical system, had a visible defect that caused the unit to lose power. Specific serial numbers of the Spectra Optia systems contain these cables and therefore there is a possibility these systems could encounter a non-recoverable power failure. If a power failure occurs prior to starting the procedure, the failure could result in the delay of the procedure until the device is repaired or another device is available. If a power failure occurs after the procedure has begun, the procedure cannot be completed, and automated rinseback cannot be performed.
To date, the manufacturer has not received any customer reports of a non-recoverable power failure experienced in any Spectra Optia system with the possibly affected cables. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Terumo is advising users that they will be replacing the affected cables. A Terumo sales representative will contact users to schedule a visit for the cable replacement. In the interim, the Spectra Optia system can continue to be used in accordance with the operator’s manual and the operator training materials, which include instructions for manual rinseback.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1300 533 507 - Terumo BCT Customer Service |