PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.
Read the official notice →- Date
- 2023-09-20
- Country
- United States
- Brand
- Philips Medical Systems Nederland
- Product
- Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
- Classification
- Class II
- Units
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-02-07
USPHILIPS 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…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide distribution.Official notice → - 2023-12-27
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7…
Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide and the countries of Albania, Algeria, Argentina,…Official notice → - 2023-09-13
- US
Philips 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 →
Other drugs & medical recalls in the United States
- 2023-09-27
- US
CareFusion 213, LLC recalls BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (1 ml) each, 60…
Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate…
FDA · DrugCareFusion 213, LLCDistributed nationwide to 100 consignees. Please refer to consignee list.Official notice → - US
AMMAN PHARMACEUTICAL INDUSTRIES recalls TRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively…
Lack of Assurance of Sterility
FDA · DrugAMMAN PHARMACEUTICAL INDUSTRIESProduct was distributed to two (2) direct accounts in RI and CO.Official notice → - 2023-09-20
- US
BioFire Diagnostics, LLC recalls FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE¿ FILMARRAY¿ Gastrointestinal (GI) Panel
FDA · DeviceBioFire Diagnostics, LLCUS:DE, AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA,…Official notice → - US
Siemens Medical Solutions USA, Inc. recalls ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 ultrasound system, the 2.0 ultrasound system will display underestimated measurement results when using an 18L6…
FDA · DeviceSiemens Medical Solutions USA, Inc.Worldwide - US Nationwide distribution including in the states of IL, WI, CA,…Official notice → - US
Baxter Healthcare Corporation recalls Welch Allyn Connex Spot Monitor
Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the state of CA.Official notice → - US
Keystone Industries recalls Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.:…
The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reline Kit (570-0717) (0921250HS) on the outer box. The contents of the Kit and the IFU enclosed with the kit were correctly…
FDA · DeviceKeystone IndustriesUS Nationwide distribution in the states of IL, PA, FL NV, TX.Official notice →