| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00988-1 |
| Product Name/Description |
Affirm Lateral Arm Upright Biopsy Accessory
(accessory to the Affirm Breast Biopsy Guidance System for Selenia Dimensions)
Catalogue Number: ASY-09880
ARTG Number: 281546 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
Hologic has received four complaints at the time of device installation that it was not possible to properly align small-diameter spring loaded core biopsy needles with the blue needle guide.
The blue needle guide is used when a lateral left side approach is chosen for biopsy. Investigation revealed a component issue that could impact needle alignment for all left approach lateral biopsy procedures. The impact on the position of the needle within the breast, and thus on the aspiration of the intended tissue, is case-dependent and can be observed in the post-fire, post-biopsy, and specimen images when those are used during a procedure.
The right side approach is not affected by the reported problem. To date, no patient injury has been reported. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
1. A replacement part (blue needle guide) is available and Hologic will schedule an appointment for a field service engineer to install the new blue needle guide.
2. Complete, sign and return the supplied customer response form. Should you have any additional questions please contact Hologic.
3. Pass this letter on to all those who need to be aware within your organisation or to any facility where the potentially affected devices have been transferred.
This action has been closed-out on 28/08/2018. |
| Contact Information |
02 9888 8000 - Hologic Technical Support |