| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00029-1 |
| Product Name/Description |
Azurion 7 M20 FlexArm system with Maquet Magnus Table
Product codes: 722079, 722224
Serial numbers: 756, 781, 1169, 1241, 703351
ARTG 370112
(Philips Electronics Australia Ltd - X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
16/01/2024 |
| Responsible Entity |
|
| Reason/Issue |
Two issues have been identified with the Azurion 7 M20 FlexArm system with Maquet Magnus Table.
1) Connection Issue: If, during a procedure, the detector is positioned at a distance of approximately four (4) cm from the patient, the connection between the FlexArm and the Table may be lost due to a software issue. When this occurs, the table and the FlexArm-System will automatically reconnect after approximately 10 seconds, during which Table movement will be unavailable.
2) Date and Time Issue: When the FlexArm system is (re)started, the FlexArm and Table may not connect due to a software issue. This occurs when the date/time format includes more than three (3) leading zeros. The connection will be established automatically once one of the leading zeros changes to a “one (1)”. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips will be installing a software update that will resolve the Date &Time Issue. This update has been released, customers will be contacted by a Philips representative to schedule these activities. Philips is working on developing a solution to correct the Connection Issue. This is expected to be available by end of Q1 of 2024.
Until Philips implements the solution, during the procedure:
a) Avoid positioning detector at 4 cm from the patient.
Be aware that the connectivity issue occurs when the detector is within 4cm of the patient – it is recommended to allow more distance (eg up to 10cm) to avoid complication & allow for subjective variation of measurement of the distance.
b) Please keep items such as drapes, surgical instruments, surgeon/nurses hands at least 4 cm from the detector.
c) If Connection Issue occurs:
1. move detector so it is no longer at 4cm from the patient.
2. if moving detector doesn't resolve the issue, restart geometry of the FlexArm |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |