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.
Read the official notice →- Date
- 2024-08-28
- Country
- United States
- Brand
- Philips Medical Systems Nederland
- Product
- Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of IL and OR. 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-11-20
USPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Zenition 50, Model Number: 718096
Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Albania, Algeria,…Official notice →- 2024-09-25
- US
PHILIPS 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 → - 2024-08-14
- 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 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 →
Other drugs & medical recalls in the United States
- 2024-09-04
- US
Dr. Reddy's Laboratories, Inc. recalls IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC…
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
- US
Glenmark Pharmaceuticals Inc., USA recalls Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count bottle…
Failed Dissolution Specifications: below specification results
- 2024-08-28
- US
Covidien recalls Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
IFU update to address device's battery handling information.
FDA · DeviceCovidienWorldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - US
NeuroLogica Corporation recalls GM60A. Digital Diagnostic Mobile X-Ray System.
Potential for the anti-fall system of the device arm to fail.
FDA · DeviceNeuroLogica CorporationUS Nationwide distribution in the states of AR, CT, GA, IN, KS, MA, MD, MO,…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar,…Official notice → - US
Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized…
Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues
FDA · DeviceIon Beam Applications S.A.IL,LA, NJ, MI,OK, TN, TX, VA, WA Foreign: Czech Republic France Germany Italy…Official notice →