Class I - Dangerous
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
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Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
Class I - Dangerous
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
Class I - Dangerous
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
Class I - Dangerous
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
Class I - Dangerous
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer.- SMN: 11206236
Siemens Healthcare Diagnostics
Class I - Dangerous
Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers
Class I - Dangerous
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
Class I - Dangerous
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995478
Siemens Healthcare Diagnostics
Class I - Dangerous
Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers
Class I - Dangerous
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
Class I - Dangerous
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
Class I - Dangerous
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
Class I - Dangerous
Due to a software error, the IAS (Image Acquisition System) may sporadically fail during startup/ restart, and result in delay of clinical treatment
Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.
Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.
Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.
Class I - Dangerous
There is an incorrect version of the needle in the introducer part of devices. The affected Lots were manufactured using needles with a needle trocar geometry which is out of specification and may require a slightly higher push force from the user to penetrate the patient skin.
Class I - Dangerous
Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001
Roche Diabetes Care
Class I - Dangerous
Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.
Class I - Dangerous
Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury