Class I - Dangerous
Product was not sterilized. Product was shipped to distribution centers instead of the sterilization facility due to an operations error by a 3rd party shipping company.
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Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
Class I - Dangerous
GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.
Multiple issues have caused the device to result in CT rescans or incorrect scan location or misrepresentation of image results.
Siemens is conducting this recall for the IMMULITE¿ 2000/IMMULITE¿ 2000 XPi Intact PTH (Intact Parathyroid Hormone) (iPTH) assay kit lot 320. Siemens has confirmed that IMMULITE¿ 2000/IMMULITE¿ 2000 XPi Intact PTH kit lot 320 can exhibit an average negative bias of up to -39% at iPTH concentrations <20 pg/mL with serum and EDTA patient samples vs. a reference kit lot.
Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: - In Artis Systems with A100 Plus or A100G generators, an attempt to resume operation following detection of a fault can result in the failure of a module in the high-voltage generator. - For biplane systems delivered with software version VD11B since April of this year, software problems in conjunction with graphics card may, in rare cases, result in the loss of image display in the examination room.
Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: - In Artis Systems with A100 Plus or A100G generators, an attempt to resume operation following detection of a fault can result in the failure of a module in the high-voltage generator. - For biplane systems delivered with software version VD11B since April of this year, software problems in conjunction with graphics card may, in rare cases, result in the loss of image display in the examination room.
Class I - Dangerous
This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user.
GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.
Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
Near-infrared spectroscopic image (Chemogram) generated by the TVC Imaging System TVC-MC9 in some cases demonstrated an unusual appearance in that the yellow in the image (indicating the presence of lipid core plaques) was horizontally-oriented
Recalling dilators included with the 6F PreludeEASE Hydrophilic Sheath Introducer because the dilator tips were manufactured with an undersized inner diameter and therefore will not allow passage of an 0.021 (0.53 mm) guide wire.
Class I - Dangerous
Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
Sterling Diagnostics
Class I - Dangerous
Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
NeuViz 64 Multi-slice CT Scanner Systems
Neusoft Medical Systems Co.
Class I - Dangerous
The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restarted to clear the interruption error before scanning can resume.
Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube Diagnostic x-ray high voltage generator.
Shimadzu Medical Systems
Class I - Dangerous
Shimadzu Medical Systems is recalling the Shimadzu X-ray High Voltage Generator due to the possibility of oil leaking from the x-ray tube housing under certain conditions.
Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
Sterling Diagnostics
Class I - Dangerous
Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
Class I - Dangerous
Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
Class I - Dangerous
Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.