Recall archive
153 recalls · page 4 of 7
Reported Dec 5, 2018
Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 28, 2018
Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Potential electric leakage affecting the user.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 21, 2018
GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Healthcare, LLC
Matched: Brand · Product · Product details — A detector can detach and fall.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 14, 2018
Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Synchronization failure
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 24, 2018
Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present.
FDA (openFDA device enforcement)
Reported Aug 8, 2018
Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Reason for recall — Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS…
9 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 1, 2018
Brivo XR385, model 5215463, Digital Diagnostic Radiographic System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — The placing of weight on the VRAD detector, of the Brivo XR385 digital radiographic system, can introduce image artifacts, which can result in…
FDA (openFDA device enforcement)
Reported Apr 11, 2018
Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Interface is an…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — if the cables of the Monica Novii System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 4, 2018
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 19, 2017
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction
FDA (openFDA device enforcement)
Reported Jun 21, 2017
GE Healthcare Revolution EVO X-ray system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details — It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
16 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 7, 2017
Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Reported incidents of a patient step detaching from the table. A fall from a patient step detaching while in use could result in an injury to a…
FDA (openFDA device enforcement)
Reported Apr 19, 2017
Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Reason for recall — GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 22, 2017
Discovery MR450 The systems are whole body magnetic resonance scanners designed to support high resolution, high…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Potential safety issue with the patient bore heating on the Discovery MR450 narrow bore 1.5T MRI. In the event of a RF component failure, typically…
FDA (openFDA device enforcement)
Reported Jan 18, 2017
Infant Warmer System (IWS)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Reason for recall — GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS).…
FDA (openFDA device enforcement)
Reported Jan 4, 2017
Innova 2000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Reason for recall — GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX,…
12 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 21, 2016
GE Healthcare, Avance, Avance CS2, Amingo.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has become aware of a potential safety issue where certain Avance CS2, Avance and Amingo anesthesia devices can transition to a System…
FDA (openFDA device enforcement)
Reported Sep 14, 2016
GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involving SIGNA CREATOR and SIGNA EXPLORER which could…
FDA (openFDA device enforcement)
Reported Jul 13, 2016
GE Healthcare, Discovery MR750w
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Discovery MR750w. A small area on the bore…
FDA (openFDA device enforcement)
Reported Jun 15, 2016
GE Revolution CT The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details — GEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can result in unintended motion in cases involving large…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 24, 2014
Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM)…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 19, 2014
GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 15, 2014
GE Healthcare Carescape Patient Data Module
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient…
FDA (openFDA device enforcement)
Reported Oct 8, 2014
GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F X-ray System is intended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has become aware of a potential safety issue involving missing screws used for mounting the overhead Video Monitor to the tray assembly…
FDA (openFDA device enforcement)
RecallNow is not a government agency. Every notice above is published by the FDA, USDA FSIS, or CPSC and links back to its source. Back to the look-up