PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected…
Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be…
Read the official notice →- Date
- 2024-02-28
- Country
- United States
- Brand
- Philips Medical Systems Nederland
- Product
- Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Philips Medical Systems Nederland recalls
- 2024-02-28
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Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide distribution in the states of NY, PA,…Official notice →- US
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Dual In-Line Memory Modules (DIMMs) may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide Distribution: US nationwide including states of: AL, AK, AR, AZ, CA,…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected…
Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide Distribution: US nationwide including states of: AL, AK, AR, AZ, CA,…Official notice → - 2024-02-07
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Loss of connectivity between the FlexArm and the Table due to a software issue related to the date/time format. This connection issue leads to a loss of movement of the arm or table.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
Loss of connectivity between the FlexArm and the Table due to a software issue.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12…
System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the…
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Other drugs & medical recalls in the United States
- 2024-02-28
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B. Braun Medical, Inc. recalls Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass Luer Lock LOR Tray…
Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.
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