Recall archive
11 recalls · page 1 of 1
Reported May 15, 2024
5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Ultrasound, Inc.
Matched: Brand · Product · Product details · Reason for recall — Ultrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not selected 2) 1, 2 non-TEE connected 3) Imaging with non-TEE…
FDA (openFDA device enforcement)
Reported Nov 15, 2023
Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model #…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Ultrasound, Inc.
Matched: Brand · Product · Product details · Reason for recall — Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 13, 2023
3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Ultrasound, Inc.
Matched: Brand · Product · Product details · Reason for recall — Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which…
FDA (openFDA device enforcement)
Reported Oct 13, 2021
Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Ultrasound Inc.
Matched: Brand · Product · Product details · Reason for recall — Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 20, 2016
EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W. Diagnostic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Ultrasound, Inc.
Matched: Brand · Product · Product details · Reason for recall — The fasteners securing the control panel assembly to the base of the Philips EPIQ Ultrasound System may loosen over time, which could subsequently…
FDA (openFDA device enforcement)
Reported Jan 13, 2016
Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Ultrasound, Inc.
Matched: Brand · Product · Product details — Color Flow direction is displayed incorrectly in Lumify 1.0. The system displayed Color Flow direction does not correctly represent the annotated…
FDA (openFDA device enforcement)
Reported Jun 24, 2015
Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Ultrasound, Inc.
Matched: Brand · Product · Product details · Reason for recall — 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…
FDA (openFDA device enforcement)
Reported May 27, 2015
EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Ultrasound, Inc.
Matched: Brand · Product · Product details · Reason for recall — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 13, 2015
EPIQ 5 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W. Catalog Number: 795204 /…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Ultrasound, Inc.
Matched: Brand · Product · Product details · Reason for recall — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 24, 2014
Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Ultrasound, Inc.
Matched: Brand · Product details — When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV)…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 30, 2014
QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Ultrasound, Inc.
Matched: Brand · Product details — The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions.
1 more product in this recall
FDA (openFDA device enforcement)
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