Class I - Dangerous
If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there is a risk of the device overheating potentially causing a burn to the user or the ear canal of the patient
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Diagnostic Equipment
🏥 Medical Devices • 6,554 recalls
Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01
Abbott Laboratories
Class I - Dangerous
Due to potential performance issues with software version 3.2.3 and earlier. Performance issues are: 1) There is the potential for onboard reagents past their lot expiration date or onboard stability time to be incorrectly displayed on the Reagent Status screen with a status of "OK". In this scenario, the expired reagent will remain in the carousel for sample processing. 2) Performing monthly maintenance procedure 5701 Clean ICT Drain Tip incorrectly may potentially cause issues such as damaged connector or leaking connection. 3) A sample exception with message code 150 "Unable to process test. Previous processing module error" is produced without notifying the operator of a reagent pipettor failure and may cause processing module to transition into the Pausing state. Tests initiated prior to the sample exception may continue to process without dispense of reagents, potentially leading to incorrect results. 4. Reagent short dispense: Alinity c needs a control measure to protect against the potential for short reagent dispense. Addition of a maximum depth limit for reagent cartridges on the Alinity c to prevent the potential for a short dispense is needed. 5. RSM indicators were blinking green incorrectly: The Reagent and Sample Manager (RSM) indicators will incorrectly blink green indicating that processing is completed and the rack or cartridge can be removed from the loading area when the rack or cartridge should not be accessed. 6. Erroneous ICT Calibration Curves: Erroneous ICT calibration curves might be generated for the Alinity c when there is a malfunction of ICT reference solution delivery, use of wrong/evaporated calibrator, defective ICT modules, etc.
Class I - Dangerous
There is potential for false positive results.
ACUSON Juniper Diagnostic Ultrasound System
Siemens Medical Solutions USA
Class I - Dangerous
Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable.
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- 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: 10995477
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
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