| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00813-1 |
| Product Name/Description |
Swoop Portable MR Imaging System Mk 1.8 and 1.9
Swoop Portable MR Imaging System Mk 1.8
Model Number: 900-11001-05
Serial numbers: HG21360037, HG21360038, HG21360039, HG21360040, HG21360041
Swoop Portable MR Imaging System Mk 1.9
Model number: 900-11001-06
Serial numbers: HG23280042, HG23280043, HG23280045
ARTG 384545
(Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Swoop Portable MRI System - MRI system, extremity imaging, permanent magnet) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
11/09/2024 |
| Responsible Entity |
|
| Reason/Issue |
Internal testing of Swoop v1 8.8 SW changes concluded that IEC 60601-1-2 Ed 4.0, clause 7.2.2 “Voltage fluctuations and flicker” needed to be repeated for the V1 system to confirm that the overall short and long-term flicker effect remained below the tolerance threshold. Results indicated the 8.8 SW exceeded the Flicker >220VAC limit of EMC testing.
A v1 system (Mk 1.9 HW 8.8 SW) sent to Intertek, resulted in a flicker failure at >220VAC. It was also determined that previous SW versions for 1.8 and 1.9 HW, available with >220VAC, may be susceptible to flickering.
The Swoop device could interact with other devices in the use environment. This interaction could manifest as disturbing normal functioning of the other devices; by causing a brief flickering to occur in the power/lighting of the other device.
This potential occurrence does not cause any injury to the patient or user and does not impact the Swoop performance. No reports have been received since device launch in 2021 |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
A remote software upgrade is anticipated by February 2025. Customers will be notified when this is available.
In the interim if the user or person observes devices or lights flickering, the risk may be temporarily mitigated by:
- Users may avoid using DWI sequences for scanning patients or
- Users may remove other devices in the immediate vicinity if they appear to be susceptible to interferences during Swoop DWI scanning. |
| Contact Information |
02 9006 1662 - Emergo Australia |