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.
Read the official notice →- Date
- 2024-06-05
- Country
- United States
- Brand
- Philips Medical Systems Nederland
- Product
- Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide in the states of CA, IN, OR and the…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-09-11
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 →- 2024-08-14
US
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
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice →- 2024-06-05
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 →US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used…
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 →
Other drugs & medical recalls in the United States
- 2024-06-06
US
Spectrum Brands Pet Care Recalls Pet Fur deShedding Conditioner Due to Risk of Exposure to Bacteria
The recalled conditioner can contain bacteria, including Pseudomonas aeruginosa, an environmental organism found widely in soil and water. People with weakened immune systems or external medical devices who are exposed…
- 2024-06-05
US
Reflexion Medical, Inc. recalls RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the…
A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
US
CareFusion 303, Inc. recalls BD Pyxis(TM) Anesthesia Station 4000, REF: 338
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
FDA · DeviceCareFusion 303, Inc.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice →US
Alcon Research LLC recalls ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic…
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
FDA · DeviceAlcon Research LLCWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice →US
Agilent Technologies recalls Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number: CS10030, CS10040,…
There is the potential for the front plexiglass door of the automated slide processing system to break causing potential injury.
FDA · DeviceAgilent TechnologiesWorldwide - US Nationwide distribution in the states of CA, TN, MI, MD, MA,…Official notice →US
MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832; b) AHS PARACERVICAL/PUDENDAL…
Trumpet Needle Guide ring can detach when excessive pressure is applied.