Integra determined there is a possibility that the Base Units may break during use.
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Diagnostic Equipment
🏥 Medical Devices • 6,554 recalls
GE Healthcare has become aware of potential issues associated with the CARESCAPE Monitor B650. There have been no reported illnesses or injuries that have occurred with the use of the device.
Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and other networked devices.
Mindray DS USA, Inc. d.b.a. Mindray North America
Class I - Dangerous
Mindray has identified a software anomaly that may where, in the presence of an asystole, the Telepack ECG waveform may produce a unique step pattern (instead of a flat line) if Lead 1 or V is being utilized for detecting cardiac arrhythmia.
Class I - Dangerous
Viterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (below the meter's measurable range) blood glucose readings from Bayer's Contour Elite XL blood glucose meters, or from Roche's Accu-Chek Advantage 03 and 04 meters to healthcare professionals.
Class I - Dangerous
GE has become aware of multiple issues affecting the Dash 3000/4000/5000 and DashPort 2 monitor. This report of correction encompasses the DashPort 2 device, in which the DashPort 2 stops communicating with the Dash, resulting in Loss of Monitoring at the CIC. The DashPort 2 status LEDs in the back of the unit indicate Unity Network and DashPort 2 to Dash communication has stopped.
Class I - Dangerous
Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits because of false positive results which may lead to misdiagnosis.
The firm is recalling the products due to a potential for false negative test results.
The firm is recalling the products due to a potential for false negative test results.
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories.
GE Healthcare
Class I - Dangerous
GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor. These issues may occur when the Ethernet controller in the XPC823 CPU on the Dash and DashPort 2 motherboard functions intermittently. GE Healthcare has identified that these issues occur most often at sites with large Unity Network installations. It should be noted that the Dash 3000/4000/5000 patient m
Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels.
Terumo Cardiovascular Systems
Class I - Dangerous
Inaccurate readings. Software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations. The accuracy on any cuvette size did not meet the specifications.
Class I - Dangerous
Viterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (below the meter's measurable range) blood glucose readings from Bayer's Contour Elite XL blood glucose meters, or from Roche's Accu-Chek Advantage 03 and 04 meters to healthcare professionals.
Class I - Dangerous
Viterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (below the meter's measurable range) blood glucose readings from Bayer's Contour Elite XL blood glucose meters, or from Roche's Accu-Chek Advantage 03 and 04 meters to healthcare professionals.
VS2+ screen may lock up and stop monitoring during patient use
Class I - Dangerous
RhMK product fungal contamination.
The firm is recalling the product due to some cartridges may contain individual discs that are not impregnated with antibiotic. The firm notified their customers of the recall with a notification letter and requested a confirmation fax back of receipt.
OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France
Hitachi Chemical Diagnostics
Class I - Dangerous
There is no evidence that a visual inspection was performed on one tray of coverslips. Possibility of a low fill volume which could lead to a false negative results.
Class I - Dangerous
Some VITROS¿ Chemistry Products Vapor Adsorption Cartridge CAT No. 6800100 cartons incorrectly contain a Particulate Cartridge Part No. J19612. In some instances, the Particulate Cartridge has been inadvertently installed on the VITROS¿ System instead of the intended VITROS¿ Vapor Adsorption Cartridge which may bias results.
Out of range (increased) HDL Cholesterol results.
COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.
Roche Molecular Systems
Class I - Dangerous
The COBAS TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JPN-IVD tests, being used with AMPLILINK software version 3.3 series and COBAS TaqMan MTB Test Kits, both CE-IVD and JPN-IVD, have an incorrect Target Elbow Max cutoff value of 48 creating the potential for false negative results to be generated for patient samples with Target Elbows in the range of 48 to 50.
Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.