Class I - Dangerous
Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet. This leak can occur sporadically in affected systems.
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Diagnostic Equipment
🏥 Medical Devices • 6,554 recalls
Siemens found a defective part in their production line which could increase risk of an electrical shock for service personnel when working inside the device during system maintenance. The risk of an electrical shock is only present when a service technician ignores several steps listed in the service manual as precautionary actions during device maintenance.
Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.
Medtronic
Class I - Dangerous
Medtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ ICM that may prematurely trigger the Recommended Replacement Time (RRT) alert in some devices. Battery capacity is not affected and the device will continue to support data collection and manual data transmissions. As part of the normal behavior of the device, 30 days after RRT status is reached, Reveal
Specific CDI¿ Blood Parameter Monitoring System 500 devices are being voluntarily recalled because the BPM Sensor Head Assemblys Thermistor, which provides the blood temperature value that results in accurate display values on the monitor, does not meet specification. This may cause inaccurate temperature measurement and inaccurate analyte display values on the CDI System 500 monitor. Terumo Cardiovascular Systems (Terumo CVS) received complaints of inaccurate temperature measurements for specific devices distributed since November 5, 2015. These include both new production devices and recently serviced devices. POTENTIAL HAZARD There have been no reported illnesses or injuries as a result of this issue. A user who is not aware that the CDI System 500 is displaying inaccurate temperature values may not manage patient temperature appropriately. Using inaccurate information to manage warming and cooling strategies for a procedure could result in prolonged time on bypass. It could also lead to unnecessarily aggressive temperature management, resulting in excessive hyper or hypothermia, with potential neurologic and organ dysfunction, or increased blood component damage. Inaccurate temperature measurement could also cause inaccurate measurements of other BPM values including potassium (K+), pO2, pCO2, and pH. The greater the temperature inaccuracy, the greater the degree of inaccuracy of these other BPM values due to the dependence of their algorithms on temperature for the calculations. Inaccurate measurement of these values could result in inappropriate patient management strategies being employed to address them with the potential to result in moderate patient injury.
Class I - Dangerous
In Artis zeego systems, angulations in the vicinity of the C-arm collision area can cause the cable inlet to become clamped and can result in mechanical damage. In Artis systems with A100Plus generators, an attempt to resume operation following detection of a fault (such as a short circuit in the X-ray tube) can result in the failure of a module in the high-voltage generator.
Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with an ID Hold status.
After importing segmentation results of the left atrium created on the Artis One system, the possibility exists for the results to be mirrored to an electro-anatomical 3D mapping system, CARTO from Biosense Webster Inc.
Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can result in a cooling system failure and subsequent system failure. This leak can occur sporadically in affected systems.
Class I - Dangerous
The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
Class I - Dangerous
The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
Class I - Dangerous
After importing, the segmentation results appear mirrored at the CARTO system and can't be used for the ablation procedure.
Class I - Dangerous
The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
Class I - Dangerous
The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
Qiagen Sciences
Class I - Dangerous
Potential for obtaining a false positive result due to the possibility of endotoxin presence.
McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1.
Mckesson Medical Immaging
Class I - Dangerous
McKesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use a non-unique image directory. This issue may cause incorrect images to be displayed for a patient.
Class I - Dangerous
Accu-Chek Inform II Base Unit might produce physical transmission errors in the form of data loss in the communication between the meter and the Data Management Systems (DMS). The issue can lead to the data loss or in the worst case to an erroneous assignment of the patient data (patient mismatch). The issue will only occur at sites using POTCT1-A communication via USB.
Class I - Dangerous
The firm discovered that the incorrect lot number was engraved on the product.
Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD).
Deerfield Imaging
Class I - Dangerous
Emergency helium venting lines (i.e. quench lines) may not have been properly installed.
Class I - Dangerous
Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover