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.
Read the official notice →- Date
- 2024-06-05
- Country
- United States
- Brand
- Philips Medical Systems Nederland
- Product
- Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.
- Classification
- Class II
- Units
- Domestic: OK International: India, Spain, U.A.E.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-08-28
USPHILIPS 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 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 → - 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 → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected…
Disk Bay 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
- 2024-06-05
- US
Smith & Nephew Inc recalls smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4
Packaging contained the incorrect size of femoral head from what was displayed on the label.
FDA · DeviceSmith & Nephew IncInternational distribution to the countries of Australia, Germany, Japan,…Official notice → - US
Lucid Diagnostics, Inc. recalls Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: EC25T10VI Software Version: N/A…
The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gastroesophageal junction or the upper…
FDA · DeviceLucid Diagnostics, Inc.US Nationwide distribution in the states of MN, MD.Official notice → - US
FUJIFILM Healthcare Americas Corporation recalls FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column,…
Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
FDA · DeviceFUJIFILM Healthcare Americas CorporationUS Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI.Official notice → - US
Mirion Technologies (Capintec), Inc. recalls Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
Complaints of unexpected detachment of the collimator have been reported.
FDA · DeviceMirion Technologies (Capintec), Inc.Worldwide - US Nationwide distribution and the countries of ALGERIA,…Official notice → - US
Covidien, LP recalls Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection,…
Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
FDA · DeviceCovidien, LPWorldwide - US Nationwide distribution in the state of NJ and the countries of…Official notice → - US
Boston Scientific Neuromodulation Corporation recalls Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32…
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients…
FDA · DeviceBoston Scientific Neuromodulation CorporationWorldwide - US Nationwide distribution including in the states of TX, WA, MT,…Official notice →