🔍 RecallPedia

All Recalls

95,075 total recalls in our database

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28,983
Food
 💊
17,685
Drugs
 🏥
38,779
Medical Devices
 🏠
9,628
Consumer Products

Discovery MR750 3.0T Product Usage: Intended use: The Discovery MR750 3.0Tsystem is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Discovery MR750 3.0T system reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

GE Medical Systems

🏥 Medical Devices Class I - Dangerous

Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

May 11, 2017 Implants & Prosthetics Nationwide View Details →

Plum 360 Infusion System

ICU Medical

🏥 Medical Devices Class I - Dangerous

Potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. This would delay initiation of therapy or interrupt an infusion.

Jun 15, 2017 Infusion Pumps Nationwide View Details →

Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders. The MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles. The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The combined system utilizes the MR for radiationfree attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

GE Medical Systems

🏥 Medical Devices Class I - Dangerous

Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

May 11, 2017 Diagnostic Equipment Nationwide View Details →

Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Brivo MR355/Optima MR360 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

GE Medical Systems

🏥 Medical Devices Class I - Dangerous

Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

May 11, 2017 Implants & Prosthetics Nationwide View Details →

LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a calibration button. The LeadCare II Lead Controls packaged in the kit lots listed in #2 below are the subject of this recall (Field Correction) action.

Magellan Diagnostics

🏥 Medical Devices Class I - Dangerous

LeadCare II Test Kits controls out of range

Jan 20, 2016 Diagnostic Equipment Nationwide View Details →

Nutrilife 29% hydrogen peroxide (H202) one-gallon bottles

Nutrilife Plant Products, of Canada

🏠 Consumer Products Class I - Dangerous

The bottle caps on the 29% hydrogen peroxide one-gallon bottles do not vent properly and can allow pressure to build up in the bottle and cause it to expand and rupture, posing fire and burn hazards.

Aug 23, 2017 Other Consumer Products Nationwide View Details →