🔍 RecallPedia

All Recalls

95,114 total recalls in our database

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28,983
Food
 💊
17,685
Drugs
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38,779
Medical Devices
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9,667
Consumer Products

Liquid Waste Bottle Kit, Catalog#10386287. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.

Siemens Medical Solutions Diagnostics

🏥 Medical Devices Class I - Dangerous

The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.

Mar 5, 2015 Diagnostic Equipment View Details →

Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.

Optimedica

🏥 Medical Devices Class I - Dangerous

Software anomaly on OptiMedica CATALYS System version 3.00.05 that may result in incorrect parameters provided for cataract incision surgeon templates and both eyes have the same parameters.

Feb 20, 2015 Other Medical Devices Nationwide View Details →

Brilliance CT 64. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Philips Medical Systems (Cleveland)

🏥 Medical Devices Class I - Dangerous

The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

Mar 16, 2015 Other Medical Devices View Details →

Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide from the blood and regulates the blood temperature. The oxygenator with diffusion membrane cannot be used for the administration of volatile anesthetic gases because the gas molecules are unable to pass through the diffusion membrane. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.

Maquet Cardiovascular Us Sales

🏥 Medical Devices Class I - Dangerous

A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of Quadrox-iD Adult Diffusion Membrane Oxygenator with Bioline and Softline Coatings, Custom Tubing Packs and Diffusion Membrane HLS Set Advanced and HIT Set Advanced Models.

Mar 5, 2015 Other Medical Devices Nationwide View Details →

SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow keys of the keyboard. Tomo images may freeze on the screen when zoomed in or out under the mode of CAREVision. Sporadic displaying error in WorkStream4D application. DB may lock under heavy and multitasks.

Apr 20, 2015 Other Medical Devices Nationwide View Details →

SOMATOM Perspective; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow keys of the keyboard. Tomo images may freeze on the screen when zoomed in or out under the mode of CAREVision. Sporadic displaying error in WorkStream4D application. DB may lock under heavy and multitasks.

Apr 20, 2015 Infusion Pumps Nationwide View Details →

SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. Product Usage: The use of the SMART ABLATE Generator and all accessories is indicated in combination with compatible therapeutic catheters for use in conventional intracardiac RF ablation procedures. The SMARTABLATE Foot Pedal is designed to initiate or discontinue operation of the SMARTABLATE System. The Foot Pedal can be connected to the SMARTABLATE RF Generator, SMARTABLATE Irrigation Pump; or SMARTABLATE Remote Control.

Biosense Webster

🏥 Medical Devices Class I - Dangerous

Biosense Webster is recalling the SMARTABLATE Generator System because Biosense Webster has received two complaints reporting that during an RMT procedure the SMARTABLATE RF Generator inadvertently delivered RF energy.

Mar 19, 2015 Surgical Instruments Nationwide View Details →

LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery.

DePuy Orthopaedics

🏥 Medical Devices Class I - Dangerous

The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants. If the LCS COMPLETE RPS Knee System is implanted and the native patella is not resurfaced, the patient may experience patello-femoral pain, potentially requiring a secondary procedure.

Mar 4, 2015 Implants & Prosthetics Nationwide View Details →

Brilliance CT Big Bore Oncology. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Philips Medical Systems (Cleveland)

🏥 Medical Devices Class I - Dangerous

The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

Mar 16, 2015 Other Medical Devices View Details →

Ingenuity CT. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Philips Medical Systems (Cleveland)

🏥 Medical Devices Class I - Dangerous

The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

Mar 16, 2015 Other Medical Devices View Details →

Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed on the Alere i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans, in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.

Alere Scarborough, Inc.

🏥 Medical Devices Class I - Dangerous

High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit.

Apr 22, 2015 Diagnostic Equipment Nationwide View Details →

HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The CARDIO HELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-hospital transport. Due to its system combination of integrated oxygenator and centrifugal pump, the HLS Set Advanced is suitable for both extracorporeal pulmonary support and cardiovascular support, and for simultaneous cardiovascular and pulmonary support.

Maquet Cardiovascular Us Sales

🏥 Medical Devices Class I - Dangerous

A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of Quadrox-iD Adult Diffusion Membrane Oxygenator with Bioline and Softline Coatings, Custom Tubing Packs and Diffusion Membrane HLS Set Advanced and HIT Set Advanced Models.

Mar 5, 2015 Infusion Pumps Nationwide View Details →

SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image recovery. Pressing undo button on the RAD subtask card or previous series button on the Image subtask card during image readout. Sporadically, during an automatic or a manual RIS update.

Apr 13, 2015 Diagnostic Equipment Nationwide View Details →

Liquid Waste Bottle, Catalog#10291587. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.

Siemens Medical Solutions Diagnostics

🏥 Medical Devices Class I - Dangerous

The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.

Mar 5, 2015 Diagnostic Equipment View Details →

RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.

RAYSEARCH LABORATORIES AB

🏥 Medical Devices Class I - Dangerous

RaySearch Laboratories AB became aware of an issue with the dose calculation for some imported VMAT plans where controls points are defined with wide gantry angle spacing.

May 8, 2015 Diagnostic Equipment Nationwide View Details →

SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for urological, gastroenterological and gynecological treatment, planning and diagnostic procedures including but not limited to: Querying and retrieving patient history information and/or previous diagnosis and images from other modalities, including X-ray examinations of the urogenital area, Ultrasound examinations, Endourological interventions, Percutaneous interventions, Laparoscopy, Application of fistula, Simple procedures, Extracorporeal shock wave lithotripsy, Uroflow/urodynamics, Pediatric radiological and therapeutic applications.

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image recovery. Pressing undo button on the RAD subtask card or previous series button on the Image subtask card during image readout. Sporadically, during an automatic or a manual RIS update.

Apr 13, 2015 Diagnostic Equipment Nationwide View Details →

MX8000 Dualv. EXP, 728130. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Philips Medical Systems (Cleveland)

🏥 Medical Devices Class I - Dangerous

The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

Mar 16, 2015 Other Medical Devices View Details →

Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical Systems. The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI).

Philips Medical Systems (Cleveland)

🏥 Medical Devices Class I - Dangerous

It was noticed that the spectroscopy voxel map did not align with the anatomical images of the phantom. This resulted in incorrect orientation of the Chemical Shift Imaging (CSI) data.

Mar 11, 2015 Diagnostic Equipment View Details →