# Major Recall Alert: AneurysmFlow Recalled Due to Unreliable Prognostic Data for Aneurysm Occlusion
Philips has issued an urgent recall of its **AneurysmFlow software** after discovering that its **mafa ratio feature** does not offer reliable prognostic information regarding aneurysm occlusion following **flow diverter stent treatments**. Despite prior warnings in the product's **Instructions for Use (IFU)** and software interface, the mafa ratio could still influence intraprocedural decision-making, potentially leading to incorrect clinical judgments. This recall is critical for the safety of patients undergoing treatment for cerebral aneurysms.
For the official recall announcement, visit the **Government of Canada Recall Website**: [AneurysmFlow Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/aneurysmflow).
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## Why This Recall is Important
Patient safety is the top priority when it comes to medical devices, especially tools used in delicate procedures, such as flow diverter stent treatments for aneurysms. Philips has revealed that the **mafa ratio displayed by the AneurysmFlow software** may incorrectly guide clinicians during these complex treatments.
### Key Concerns:
- **Misleading Data**: The mafa ratio is not designed to provide reliable prognostic information on aneurysm occlusion, thus diagnosing or managing cases based on this could result in **suboptimal outcomes**.
- **Contradictory Instructions**: Despite clear warnings in the **IFU (Section 9.2 Measuring Flow)** and screen prompts, the displayed mafa ratio may still affect clinical decisions mid-procedure.
- **Potential Risks**: Inaccurate clinical decision-making could lead to **unnecessary risks for patients**, including increased procedural complications or delayed treatment efficacy.
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## Details of the Recall
This recall specifically applies to **Philips AneurysmFlow**, which is used to analyze blood flow in aneurysms treated with flow-diverter stents. Below are the key details:
- **Category**: CAN (Canada)
- **Affected Brand/Software**: AneurysmFlow by Philips
- **Recall Reason**: The **mafa ratio** does not offer reliable prognostic data and could improperly influence medical decisions.
- **Warnings in Place**:
- The **IFU (Section 9.2 Measuring Flow)** advises that the mafa ratio should not be used for clinical decision-making.
- An **on-screen message** under the mafa ratio header reiterates this caution.
- **Issue Identified**: The displayed mafa ratio may continue to impact intraprocedural decisions despite the provided warnings.
Clinicians and healthcare facilities should exercise immediate caution and reference the official notice for more details on mitigating risks.
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## What You Should Do
If you are using **AneurysmFlow in clinical settings**, here’s what you need to do:
- **Follow Manufacturer Guidance**: Temporarily discontinue reliance on AneurysmFlow until further updates are provided by Philips.
- **Refer to the IFU**: Always adhere to the **Instructions for Use** and avoid using the mafa ratio to make clinical decisions.
- **Monitor Patient Outcomes**: Ensure that any past treatments completed while referencing the mafa ratio do not have adverse effects. Exercise vigilance in follow-up procedures.
- **Contact Philips Support**: Reach out to the manufacturer for additional instructions or alternative solutions.
For more details, consult the **official recall notice**: [AneurysmFlow Recall Information](https://recalls-rappels.canada.ca/en/alert-recall/aneurysmflow).
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## Stay Safe – Get Instant Recall Alerts
Medical professionals and healthcare providers need to stay informed about recalls like this to ensure patient safety. **Download the latest Recall Alert app** to receive instant notifications for updates on medical device recalls and safety measures.
By staying proactive, you can avoid the risks associated with faulty or unreliable diagnostic tools. Stay ahead of the curve and protect your patients with the **Recall Alert app today!**
For further recall updates on the AneurysmFlow, refer to the **official source**: [AneurysmFlow Recall Details](https://recalls-rappels.canada.ca/en/alert-recall/aneurysmflow).
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By remaining informed and vigilant, healthcare professionals can make well-informed, safe clinical decisions that prioritize patient health, even in challenging situations.