🏥 Medical Devices • 6,627 recalls
Toshiba American Medical Systems
Toshiba American Medical Systems (TAMS) is recalling the Xario Diagnostics Ultrasound System because it may become hot because of a software error.
Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after the images were ingested in PACS.
Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement.
Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after the images were ingested in PACS.
MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.
MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
The possibility exists for contaminants, in the form of biomass, to develop in the cooling system of Artis systems resulting in damage to the pump system.
The possibility exists for contaminants, in the form of biomass, to develop in the cooling system of Artis systems resulting in damage to the pump system.
Philips Medical Systems (Cleveland)
The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: 1. During the filming operation on MX16-slice console software, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to copy the current patients images before pasting, a previous patients images may be present in the clipboard and be copied onto the film of the current patient. 2. During the Bolus Tracking scan, if the Auto Voice in Tracker scan is enabled, the Tracker scan will be aborted unexpectedly and the diagnostic scan after the tracker scan needs to be manually started. 3. If the scan protocol with SAS (Spiral Auto Start) function is selected to plan the scan, the SAS option may not be displayed on the Contrast tab of the scan protocol parameter area or the SAS option is displayed but not enabled as pre-configured in the protocol. This issue only occurs on the first helical scan after system startup that applies SAS function
The possibility exists for contaminants, in the form of biomass, to develop in the cooling system of Artis systems resulting in damage to the pump system.
The rear gradation scale was screen printed upside down on the flowmeter gauge.
Due to an error in the 19 Live Display, image reproduction may fail in the examination room and the potential exists for the loss of images immediately after system startup.
Ortho Clinical Diagnostics has issued a recall of their VITROS immunodiagnostics Estradiol Reagent assay. The firm was made aware of a potential cross-reactivity between the drug Fulvestrant and theVITROS Immunodiagnostic Estradiol Reagent assay. The firm conducted an internal investigation and was able to confirm biased positive (ranging from 1303-4046%) on Estradiol results, obtained from postmenopausal females taking Fulvestrant.
Internal review found that some vials of CD3/CD4/CD45 state that the product contains gelatin. The product does not contain gelatin and should state in buffer.
The rear gradation scale was screen printed upside down on the flowmeter gauge.
Siemens Healthcare Diagnostics
Software defect, where either an Above Assay Range or an inaccurate value could potentially be reported, in the Stratus CS Acute Care Diagnostics System regarding TestPak calibration and quality control (QC) status when a TestPak is due to expire within 48 hours.
Philips Medical Systems (Cleveland)
The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: 1. During the filming operation on MX16-slice console software, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to copy the current patients images before pasting, a previous patients images may be present in the clipboard and be copied onto the film of the current patient. 2. During the Bolus Tracking scan, if the Auto Voice in Tracker scan is enabled, the Tracker scan will be aborted unexpectedly and the diagnostic scan after the tracker scan needs to be manually started. 3. If the scan protocol with SAS (Spiral Auto Start) function is selected to plan the scan, the SAS option may not be displayed on the Contrast tab of the scan protocol parameter area or the SAS option is displayed but not enabled as pre-configured in the protocol. This issue only occurs on the first helical scan after system startup that applies SAS function
Several customer complaints about amplification performance issues when using different batches of MagSil with the NucliSENS easyMAG extraction platform.
Incorrect CO2 readings with some patient monitors.