Recall archive
353 recalls · page 11 of 15
Reported Jan 6, 2016
Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand · Reason for recall — The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 23, 2015
GE Healthcare Optima CL323i Product Usage: The angiographic X-ray systems are indicated for use for patients from…
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 related to a non-recoverable loss of displayed imaging (loss of monitor video)…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 16, 2015
GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular…
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 issue with routine head scans on your Revolution CT scanner. A potential hazardous situation…
FDA (openFDA device enforcement)
Reported Nov 18, 2015
GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Product · Product details — When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling.…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 11, 2015
The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand — Inaccurate distance measurements with magnified projection X-ray images.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 14, 2015
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Product · Product details — Images may be missing when a system parameter MapRoute is set to a value greater than 1.
FDA (openFDA device enforcement)
Reported Sep 30, 2015
Lightspeed 16 CT
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand — Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 2, 2015
Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand — Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter MapRoute is set to a…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2015
GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Product · Product details — A gradient cable in the ACGD cabinet may be missing a spacer that prevents connecting the gradient cable terminals in the wrong polarity on X…
FDA (openFDA device enforcement)
Reported Aug 12, 2015
Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN End Tidal CO2 (EtCO2)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — A system freeze-up of the Merge Hemo system, that included the PHASEIN End Tidal CO2 unit, resulted in the user needing to move the patient to…
FDA (openFDA device enforcement)
Reported Jul 29, 2015
GE Healthcare Precision 500D Classical R & F system.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Product · Product details — A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 8, 2015
GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnostic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Product · Product details — The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is installed to hold and prevent the…
13 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 1, 2015
GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blood pressure measurements and exercise…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has recently become aware of a potential safety issue due to uncontrolled motion of the walking belt on your T2100 Treadmill.
FDA (openFDA device enforcement)
Reported Jun 3, 2015
D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules E/M-C(Ai)O(V)(X)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Product details — A potential safety issue due to loss of gas monitoring associated with occlusion of specific D-Fend / D-Fend+ water traps used with Compact Airway…
FDA (openFDA device enforcement)
Reported May 27, 2015
CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head and whole body CT scanner…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Reason for recall — GE Healthcare has become aware that 3 bolts that secure a power supply to the rotating side of the gantry were over-torqued on certain Lightspeed 16…
FDA (openFDA device enforcement)
Reported May 20, 2015
GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Product · Product details — The heart rate could be calculated from pacer pulses without indication that pacemaker detection is OFF in some combinations of Bx50 monitors, a PDM,…
FDA (openFDA device enforcement)
Reported May 13, 2015
GE Discovery MR950 MRI system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Product · Product details — The alignment lasers are missing the labels required by radiation safety regulations.
FDA (openFDA device enforcement)
Reported May 6, 2015
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Product · Product details — An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 22, 2015
Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has recently become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical…
FDA (openFDA device enforcement)
Reported Apr 8, 2015
GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines. Model numbers 1009-9012-000. Intended to provide general…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Product · Product details — Specific Aespire 7900 Anesthesia Machines have an increased likelihood of failure of the CPU circuit board. This could result in a blank display or…
FDA (openFDA device enforcement)
Reported Apr 1, 2015
GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites.
FDA (openFDA device enforcement)
Reported Mar 25, 2015
GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Product · Product details — Potential failure of the caster mounting hardware, which may result in the ventilator falling/tipping (overbalancing).
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 18, 2015
GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for use in generating radiographic images of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Product · Product details — Potential breakage of the steel cable which supports the bucky device in certain wall stands of Proteus XR/a X-ray imaging systems. A fall of a bucky…
FDA (openFDA device enforcement)
Reported Mar 4, 2015
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Product details — Using Merge Exam in single Study Mode may result in Missing Study Record (Cannot Display Exam, Send Exam, etc). Exam merge in Single Study Mode may…
FDA (openFDA device enforcement)
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