| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00845-1 |
| Product Name/Description |
Nicolet Elite Doppler Probe 2 MHz and 3 MHz Obstetric, 5 MHz Vascular
ARTG Number: 128657 (Swirl Technologies Pty Ltd T/A Parker Healthcare - Ultrasound system, non-imaging, Doppler blood-flow measurement)
Serial Number(s):
Model: 3 MHz Obstetric
Serial Number: CAQ0472 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has advised that some devices have excessive background noise. This has been determined to be caused by an issue with the transistor circuit. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Complete the supplied Verification Facsimile/Email Reply Form and then return it as directed to Parker.
If any of the investigated products have been transferred to another facility, please immediately let that facility know of this Recall for Product Correction, and record it on the Verification Facsimile/Email Reply Form.
If the excessive noise is suspected to be present, or you have any Technical inquiry, please contact Parker Healthcare Service Department as directed.
These units will be returned to the Manufacturer in the USA for product correction.
This action has been closed on the 17/09/2018 |
| Contact Information |
03 9872 0222 - Parker Healthcare |