| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00501-1 |
| Product Name/Description |
Horizon DXA System
Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI
Manufacture Date: 11/March/2022 onward
ARTG: 400491
(Hologic (Australia & New Zealand) Pty Ltd - X-ray system, diagnostic, bone absorptiometer, dual-energy) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
During standard compliance testing, Hologic identified a non-conformance in Horizon DXA devices.
The non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601 – 1 – 2 for the safety and essential performance of medical electrical equipment, where the result from the Horizon DXA System exceeded the electromagnetic compatibility limit.
Potential risks have been identified for humans who have active, implanted medical devices. Additionally, there is potential risk of interference with the essential performance other electronic medical devices in close proximity to the equipment. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to acknowledge the following:
• Do NOT scan patients that have active implanted medical devices, including but not limited to neurostimulators, pacemakers, cardiac defibrillators, continuous glucose monitors, or other bio-wearable sensors.
• Any operator who has an active implanted medical device should also refrain from operating the system at this time.
• Do NOT scan patients that are currently being treated with an electronic medical device.
Hologic is urgently investigating the permanent rectification actions required, and we will be in contact promptly once this is defined. Until the rectification is completed, the customer letter and the specific warnings within it supersedes information provided on the Horizon DXA labelling and IFU pertaining to electromagnetic compatibility and electromagnetic interference. |
| Contact Information |
1800 264 073 - Hologic Technical Support |