The firm found that the top cover of the mattresses were delaminating.
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Diagnostic Equipment
🏥 Medical Devices • 6,554 recalls
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Class I - Dangerous
Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators
Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation.
Hitachi Medical Systems America
Class I - Dangerous
The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.
Spacelabs Healthcare
Class I - Dangerous
The transmitter display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions. This is an expansion of recall Z-0871-2014 because additional serial numbers were identified as being part of this recall action as part of the firm's retrospective analysis of all recalls since 2011.
Class I - Dangerous
Nanosphere has recieved reports related to an unacceptable increase in initial no-call rate when performing the Verigene CYP2C19 Nucleic Acid Test (2C19), which has been confirmed through internal testing.
Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338.
Siemens Healthcare Diagnostics
Class I - Dangerous
The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury to the operator.
The firm became aware of a potential problem that was initiated by a customer complaint. After consultation with the manufacturer, it was discovered that a resistor was incorrectly placed within the circuit board on the monitor. This change to the resistor was a planned change to address a product improvement (improve battery drain). However, this modification rendered the monitor's alarm via the nurse call communication port to not function.
The blood pressure (BP) circuit occasionally fails to inflate the blood pressure cuff and the BP circuit fails to activate, resulting in no BP measured.
Class I - Dangerous
In specific situation a partially truncated file may be written to the IntelePACS server. This partially truncated file still can be viewed by InteleViewer and InteleViewer will report to the user that the file in question is complete. This situation only occurs if a file is partially truncated.
The wireless function of the IP5 radio could be interrupted causing loss of wireless communication between the IP5 and host monitoring system.
Medtronic MiniMed is recalling the Guardian REAL-Time monitors because of a manufacturing issue that has the potential to compromise the water resistance of the affected Guardian monitors.
Class I - Dangerous
Unit was mislabeled with a factory label showing 32 KW output power.
Some sheets of the medical screen film are fogged.
Nanosphere Inc. has recently determined through four customer complaints that a small number of Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) Extraction Trays in Lot 042914021B have low levels or are missing Magnetic Microparticles (MMPs) required for DNA Extraction.
Nanosphere has received report of an increased rate of "No Call - INT CTL 2" results for the Internal Control 2 (INT CTL 2) when negative samples are tested with certain lots of CDF Amplification Trays (20-011-022), which are contained in the CDF Amplification Reagent Kit (20-012-022); specifically for lots 061913022D and 071813022E.
Class I - Dangerous
Customers may receive positively biased results when using VITROS¿ Immunodiagnostic Products CA 19-9 Total Reagent Packs, Lot 1320 and VITROS¿ CA 19-9 Calibrators, Lot 1320 on the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. There is an unexpected observed change in CA 19-9 Calibrators, Lot 1320 calibrator values.
Class I - Dangerous
Some customers reported that while using the DX-D600 in room or exam preparation, the Overhead Tube Crane (OTC) showed increased velocity and uncontrolled longitudinal movement.
The following software issues have been identified in the affected products. Problem 1: When reopening a bookmark generated from processing a MUGA (Multi-Gated Acquisition) scan within the NM Cardiac Application, the ejection fraction (EF) displayed should be the same as the ejection fraction (EF) originally displayed when the bookmark was first created. In some instances, the ejection fraction (
Customer complaints about not repeatable results below the detection limit (<45 ng/mL). Therefore false negatives are being reported for results around the medical decision point of 500 ng/mL that initially tested at <45 ng/mL.