PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for…
Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart
Read the official notice →- Date
- 2024-08-14
- Country
- United States
- Brand
- Philips Medical Systems Nederland
- Product
- Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Afghanistan,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-09-25
USPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7…
Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Nationwide, Canada and Worldwide: Albania Algeria Argentina Armenia Australia…Official notice →- 2024-09-11
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers…
The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution.Official notice → - 2024-08-28
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010,…
A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution in the states of IL and OR. The…Official notice → - 2024-06-05
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of…
Potential for pressure wave data synchronization from two devices may not be correct.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide in the states of CA, IN, OR and the…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.
When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Domestic: OK International: India, Spain, U.A.E.Official notice → - 2024-02-28
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive…
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 →
Other drugs & medical recalls in the United States
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Steris Corporation recalls Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope…
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