Recall archive
46 recalls · page 2 of 2
Reported Mar 19, 2025
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.V.
Matched: Brand — Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.
FDA (openFDA device enforcement)
Reported Mar 12, 2025
Philips IntelliSpace Cardiovascular software, Model 830089.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.V.
Matched: Brand · Product · Product details — Study data is not able to be archived, copied, or exported with the cardiovascular software version.
FDA (openFDA device enforcement)
Reported Feb 26, 2025
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
High riskUsing this product could cause serious injury, illness or death — stop using it now.Philips Medical Systems Nederland B.v.
Matched: Brand — Possibility of the patient falling from the table related to the mattress used on the patient table.
19 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 12, 2025
Allura CV20 System Code: 722031
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details · Reason for recall — Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During…
18 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 18, 2024
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details · Reason for recall — Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Root cause is…
FDA (openFDA device enforcement)
Reported Nov 20, 2024
Philips Zenition 50, Model Number: 718096
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details · Reason for recall — Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2024
System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details — 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…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 11, 2024
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details — The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to…
FDA (openFDA device enforcement)
Reported Aug 28, 2024
Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details — A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.
FDA (openFDA device enforcement)
Reported Aug 14, 2024
Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details — Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart
FDA (openFDA device enforcement)
Reported Jun 5, 2024
Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details — 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…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 28, 2024
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details — Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or…
7 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 7, 2024
Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details · Reason for recall — 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…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 27, 2023
Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 722003 Allura Xper FD10 722006…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 20, 2023
Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details — A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.
FDA (openFDA device enforcement)
Reported Sep 13, 2023
Allura Xper series
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.V.
Matched: Brand — A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 6, 2023
Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details — Loss of availability of the wireless foot switch during procedures.
FDA (openFDA device enforcement)
Reported Aug 9, 2023
Allura Xper FD10 and FD20. X-ray Imaging System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details — The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 7, 2023
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)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details — 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…
FDA (openFDA device enforcement)
Reported Apr 26, 2023
SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand — There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 11, 2022
Azurion systems with software release R1.x
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Product · Product details · Reason for recall — 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…
FDA (openFDA device enforcement)
Reported Feb 23, 2022
Zenition 50, Model #718096
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
Matched: Brand · Reason for recall — 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…
2 more products in this recall
FDA (openFDA device enforcement)
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