Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly account for this ring angle correction during the calculation of the corresponding couch shift. This may result in the treatment couch not moving to the exact planned position resulting in a deviation between the planned and the treatment target position. This deviation may not be clearly visible to the user if no verification image of the patient position is acquired after this couch shift has been performed.
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Diagnostic Equipment
🏥 Medical Devices • 6,554 recalls
BD has recently confirmed quality control failures, related to a manufacturing issue, for the inducible macrolide-linosamide-streptogramin B (iMLSb) test contained on lot 7031818 of Phoenix panels. The iMLSb resistance D-test screen for Staphylococcus species is used to identify phenotypic drug resistance to clindamycin and erythromycin. As the product should not be used when quality control (QC) fails, it is unlikely that there would be any impact on patient results, however, if a customer does not perform QC testing and uses the panel, there is a potential to incorrectly treat a Staphylococcus infection with clindamycin based on the iMLSb test result. This issue can be detected 100% of the time when used per package insert instructions with iMLSb positive strain S. aureus BAA-977.
On certain Impacted Systems, an unexpected Microsoft Windows Security dialog may appear during use, and the users response to the dialog may adversely affect the subsequent operation of the device.
Class I - Dangerous
There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
A design change was initiated to update ROSA Spine 1.0.2 to version ROSA Spine 1.0.2.16 to resolve software bugs and improve usability and stability of the ROSA Spine device.
The software issue described was corrected in the modification to the MXTTOUT controller parameter settings.
3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
3M Company - Health Care Business
Class I - Dangerous
During a recent investigation, 3M confirmed that a programming translation error could occur in a small amount of the sensors that could lead to a temperature readout that is lower than the patients actual temperature.
Siemens is releasing a non-medical software application LTA Incomplete Archive Check Tool V1.0. It is intended to eliminate an issue that occurs during syngo.plaza de-archiving from Dicom LTA. It has been defined that the number of de-archived images is less than the count of the archived images for the series. The issues were discovered through Siemens Global Complaint Handling System.
Software corrections reactivating the cooperative endoscopy mode.
Observed instability of the device.
The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. The failure occurs when the system with the Broad Quantification option is calibrated with phantoms that do not have a volume of 6500ml and/or when residual dose needs to be entered.
The system may duplicate sample requests leading to sample misidentification when connected to a Laboratory Information System (LIS)
The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. The failure occurs when the system with the Broad Quantification option is calibrated with phantoms that do not have a volume of 6500ml and/or when residual dose needs to be entered.
Possible break in the connector of the Force Sensor.
Potential failure of the optical distance sensor due to cable disconnection.
Intermittent communication between the host system and the Flex Cardio
North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industrial x-ray imaging of product hardware
North Star Imaging
Class I - Dangerous
It was discovered a low-level radiation leak that was found on the NSI X-7000 system.
A specific lot of the FlexFlowTM Venous Cannula, 200-200, is being recalled because it is sharper or pointier than expected.
Class I - Dangerous
The US FDA has requested the optional energy treatment settings, "medium" and "low" (Software Protocols 02-Medium and 03-Low) be removed from all Ablatherm Integrated Imagining devices in the U.S. until supporting clinical data can be submitted and evaluated by FDA.
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Hologic
Class I - Dangerous
An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.