PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion systems with software release R1.x
In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a…
Read the official notice →- Date
- 2022-05-11
- Country
- United States
- Brand
- Philips Medical Systems Nederland
- Product
- Azurion systems with software release R1.x
- Classification
- Class II
- Units
- US Nationwide and Worldwide 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-09-13
USPhilips Medical Systems Nederland B.V. recalls Allura Xper series
A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
- 2023-09-06
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems
Loss of availability of the wireless foot switch during procedures.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2023-08-09
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M20. X-ray Image guided Therapy System.
The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2023-06-07
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1)…
Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Nationwide Foreign: Algeria Argentina Armenia Australia Austria Bahrain…Official notice → - 2023-04-26
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution.Official notice → - 2022-02-23
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Zenition 50, Model #718096
Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Domestic distribution to AZ CA FL GA HI IL KS KY MA MD ME MI MN MS NC NE NJ NV…Official notice →
Other drugs & medical recalls in the United States
- 2022-05-11
- US
Baxter Healthcare Corporation recalls Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to…
There is a potential for foreign matter.
FDA · DeviceBaxter Healthcare CorporationDistribution in the United States including AL, CA, KY, NY, OR, PA, and TX OUS…Official notice → - US
Becton Dickinson & Co. recalls BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic codes.
FDA · DeviceBecton Dickinson & Co.Worldwide distribution US Nationwide distribution in the states of CA, IL, MI,…Official notice → - US
SML Distribution, LLC recalls Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
The product was distributed without FDA authorization or clearance for marketing and distribution in the US.
FDA · DeviceSML Distribution, LLCUS Nationwide distribution in the states of AL, FL, GA, MO, NY, TX, and WY.Official notice → - US
Best Brands Consumer Products, Inc. recalls The Mandalorian Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./60 mL bottles, Best Brands Consumer Products, Inc., c/o Best…
Chemical Contamination; FDA analysis found product to contain benzene
- US
Best Brands Consumer Products, Inc. recalls Mickey Mouse Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./to mL bottle, Best Brands Consumer Products, Inc., c/o Best Brands…
Chemical Contamination; FDA analysis found product to contain methanol
- US