Philips Ultrasound, Inc. recalls
26 recalls in our records from 2014 to 2026: 26 FDA medical devices.
Recalls with full detail pages
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Philips Ultrasound, LLC medical device recall: Philips Lumify Diagnostic Ultrasound System
Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which may be unavailable…
Earlier and other recalls
These link to the official agency notice.
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Philips Ultrasound, LLC medical device recall: Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 Official notice ↗
Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow…
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Philips Ultrasound, Inc medical device recall: Philips 3D6-2 Ultrasound Transducer Official notice ↗
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Philips Ultrasound, LLC medical device recall: Philips EPIQ Ultrasound Systems Official notice ↗
Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.
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Philips Ultrasound, LLC medical device recall: Lumify Diagnostic Ultrasound System models : 795005 Official notice ↗
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
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Philips Ultrasound, Inc medical device recall: 3D6-2 Transducer Probe Official notice ↗
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Philips Ultrasound, Inc medical device recall: Philips 3D9-3v Transducer Official notice ↗
Ultrasound transducer devices were refurbished beyond their useful life.
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Philips Ultrasound, Inc. medical device recall: 5000 Compact Series Ultrasound Systems Official notice ↗
Ultrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not selected 2) 1, 2 non-TEE connected 3) Imaging with non-TEE 4) Selected/not…
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Philips Ultrasound, Inc. medical device recall: Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model #… Official notice ↗
Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image.
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Philips Ultrasound, Inc. medical device recall: 3D9-3v Transducer Official notice ↗
Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users…
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Philips Ultrasound Inc medical device recall: EPIQ CVxi Diagnostic Ultrasound Systems Official notice ↗
Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unresponsive system, necessitating system restart, which could lead to…
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Philips Ultrasound Inc medical device recall: Philips Ultrasound Official notice ↗
Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of alternating current…
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Philips Ultrasound Inc medical device recall: EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0 Official notice ↗
Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.
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Philips Ultrasound Inc medical device recall: EPIQ Ultrasound Systems Official notice ↗
Ultrasound system control panel arm swivel lock could fail, which could cause the control panel and monitor to swivel freely while a user is positioning the monitor, or…
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Philips Ultrasound Inc medical device recall: Philips EPIQ Diagnostic Ultrasound System Official notice ↗
Control panel arm assembly could have missing or loose screws where undue force, pressure or weight is applied, the control panel mechanism can fail and break off.
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Philips Ultrasound Inc medical device recall: Philips EPIQ Diagnostic Ultrasound System Official notice ↗
The manufacturer discovered an issue associated with the EPIQ Image Boost with xPlane and Color Flow or Doppler while using the X8-2t TEE Transducer. If Image Boost is…
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Philips Ultrasound Inc medical device recall: All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G Official notice ↗
The manufacturer has determined that with certain uncommon workflows there is potential for incorrect patient data to be displayed and saved into an exam. The issue(s)…
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Philips Ultrasound Inc medical device recall: Transducer S7-3t UDI Official notice ↗
The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. As a result, the system…
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Philips Ultrasound Inc medical device recall: Philips EPIQ and Affiniti Ultrasound Systems with software version… Official notice ↗
There is a potential that the image of one patient could get unexpectedly moved into another patient's folder when the user is using the Edit functionality on the…
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Philips Ultrasound, Inc. medical device recall: Epiq Diagnostic Ultrasound System Official notice ↗
The fasteners securing the control panel assembly to the base of the Philips EPIQ Ultrasound System may loosen over time, which could subsequently lead to the detachment…
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Philips Ultrasound, Inc. medical device recall: Philips Lumify Diagnostic Ultrasound Official notice ↗
Color Flow direction is displayed incorrectly in Lumify 1.0. The system displayed Color Flow direction does not correctly represent the annotated Color Bar or Velocity…
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Philips Ultrasound, Inc. medical device recall: Philips Ultrasound Official notice ↗
Philips Healthcare has discovered a problem in the Philips Ultrasound Q-Station version 3.0 or higher that could result in measurements from a study (Structured Report)…
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Philips Ultrasound, Inc. medical device recall: EPIQ 5 Ultrasound System versions 1.3.2 or lower Official notice ↗
When EPIQ 5 Ultrasound System, WITHOUT the Pediatric Cardiology option, is set up to "Metric" and weight and/or height is entered, a unit conversion error may result in…
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Philips Ultrasound, Inc. medical device recall: EPIQ 5 Ultrasound System with Pediatric Cardiology option Official notice ↗
When Epiq 5 Ultrasound System, WITH the Pediatric Cardiology option, is set up to Metric and weight and/or height is entered, a unit conversion error may result in the…
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Philips Ultrasound, Inc. medical device recall: Additional devices identified in new FSN MA-FCO 83000190: QLAB… Official notice ↗
When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be smaller, and…
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Philips Ultrasound, Inc. medical device recall: QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is… Official notice ↗
The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions.
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.