Recall archive
353 recalls · page 7 of 15
Reported Apr 3, 2019
Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.GE Healthcare, LLC
Matched: Brand · Product details — The Integrated ECG cable with 3-lead leadwires can short circuit during defibrillation and conduct 25% of the defibrillation energy away from the…
FDA (openFDA device enforcement)
Reported Mar 6, 2019
The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging System Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds the allowable limits for medical devices. Leakage…
FDA (openFDA device enforcement)
Reported Feb 13, 2019
Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation and on the gantry display may not be…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 6, 2019
GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage: The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details — Increased temperature in the probe-head surface with LOGIQ P6 Model BT07 and BT09 scanners when used in specific types of scans and with specific…
FDA (openFDA device enforcement)
Reported Jan 16, 2019
Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details — Possible incorrect software version loaded.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 26, 2018
Omnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vial, packaged in 10 x 20 mL Vials per carton, Rx only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare Inc. Life Sciences
Matched: Brand · Product details — Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance…
FDA (openFDA drug enforcement)
Reported Dec 26, 2018
Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 SP7, SP7.0.1,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Issue #1 affects Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2. When an image is flipped horizontally and…
FDA (openFDA device enforcement)
Reported Dec 19, 2018
PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 is a portable multiparameter unit…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Patient monitors may restart due to network overload caused by network configuration.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 12, 2018
GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box…
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Healthcare, LLC
Matched: Brand · Product · Product details — The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. As a result, this could create a loss of ventilation…
FDA (openFDA device enforcement)
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
DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare Biosciences
Matched: Brand — Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion to make the interlock system single-fault tolerant.
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 31, 2018
GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite…
2 more products 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 Oct 24, 2018
GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product · Product details — The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 17, 2018
GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare Finland Oy
Matched: Brand · Product · Product details — When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 12, 2018
McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.McKesson Israel Ltd.
Matched: Reason for recall — Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals.
FDA (openFDA device enforcement)
Reported Aug 29, 2018
GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are intended for head, whole body,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare Japan Corporation
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.
3 more products in this recall
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 8, 2018
Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand · Product · Product details — The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
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 Jul 11, 2018
GE Healthcare CARESCAPE Monitor B650
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare Finland Oy
Matched: Brand · Product · Product details — When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may…
FDA (openFDA device enforcement)
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