Class I - Dangerous
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Class I - Dangerous
This recall has been initiated due to a defective component within the handpiece which will cause the handpiece to fail. The failure will result in the inability to cut tissue with the handpiece, rendering it non-functional. Should this failure occur, a replacement Myriad handpiece will be required. If a replacement handpiece is not available, alternate instrumentation for tissue removal will be necessary.
Class I - Dangerous
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Medtronic is issuing a medical device recall to return product potentially associated with an outer box mislabel issue for two Protege EverFiex" Self-expanding Peripheral Stent Systems, model PRB35-08-040- 080, from lot A164580. The size on the outer box is labeled as 8x40x80mm while potentially containing a 6x40x120mm device as indicated by both the inner pouch and device labels. This potential issue is limited to two EverFiex stent system devices from lot A164580 that were repackaged by Medtronic and distributed. This does not affect any other Medtronic product or implantable devices.
Class I - Dangerous
Cell Marque became aware of some lots of SIOOA I (EP I84) Rabbit Monoclonal Antibody, catalogue numbers 408R-14, 408R-15, and 408R-16, that exhibited an unacceptable IHC test result.
Class I - Dangerous
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Biograph mCT-X 3R, MATERIAL NUMBER 10248673 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Siemens Medical Solutions USA
Class I - Dangerous
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Class I - Dangerous
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead
Class I - Dangerous
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Class I - Dangerous
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Class I - Dangerous
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Class I - Dangerous
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Class I - Dangerous
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Class I - Dangerous
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Class I - Dangerous
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N
SSC- Surgical Specialties
Class I - Dangerous
Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP because it may contain Black Nylon 9-0 suture.
Class I - Dangerous
Exhibits a greater than 10% change in results in samples with biotin levels up to 10 ng/mL (41 nmol/L). Instructions for Use (IFU) states that specimens that have up to 10 ng/mL (41 nmol/L) of biotin
Class I - Dangerous
The device was found to have bacterial contamination.