If the beam model has a highly asymmetric primary source, it is not correctly taken into account in the calculation of DMLC fields when the collimator is rotated. This could lead to potentially significant overdosage at delivery. The user must be aware of the issue to avoid incorrect dose calculations during treatment planning.
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Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
Increase of events affecting performance regarding pump clogging and displacement of the color-coded SPR label (DOT). These performance issues could contribute to erroneous results for any assay performed on the VIDAS¿ and mini VIDAS¿ system due to a decrease of pipetted volume.
Some printing modes on the devices may not function properly (tabular data printing, real-time continuous printouts, and automatic interrupt print feature).
Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results
Class I - Dangerous
Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of non-thrombogenic .
PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.
Dako North America
Class I - Dangerous
To correct the kit's instructions for use as the storage time for gastric and gastroesophageal junction adenocarcinoma cut sections will be changed from six months to five months.
Increase of events affecting performance regarding pump clogging and displacement of the color-coded SPR label (DOT). These performance issues could contribute to erroneous results for any assay performed on the VIDAS¿ and mini VIDAS¿ system due to a decrease of pipetted volume.
Class I - Dangerous
Incorrect hCG results
The device may give a falsely elevated result that is non-reproducible. If vitamin D level is monitored by laboratory tests and adapted based on the result, a dosage reduction of vitamin D supplementation cannot be excluded, and as a consequence, vitamin D deficiency may develop over time.
The device may give a falsely elevated result that is non-reproducible. If vitamin D level is monitored by laboratory tests and adapted based on the result, a dosage reduction of vitamin D supplementation cannot be excluded, and as a consequence, vitamin D deficiency may develop over time.
GE Healthcare CARESCAPE Monitor B650
GE Healthcare Finland Oy
Class I - Dangerous
When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.
The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Insertable Cardiac Monitoring (ICM) devices. This drop is an expected and normal behavior for this battery chemistry, but causes an incorrect display of a low battery indicator even after the battery voltage returns to normal.
VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
Ortho-Clinical Diagnostics
Class I - Dangerous
There is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and lower than expected results for both quality control samples and patient samples.
Invalid calibration with low calibrator S1 while using the product.
Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 The power supply unit may be damaged and may fail to start up when the power plug is inserted into a power outlet while the main power switch on the rear of the system is set to ON.
Toshiba American Medical Systems
Class I - Dangerous
The power supply unit may be damaged and may fail to start up when the power plug is inserted into a power outlet while the main power switch on the rear of the system is set to ON.
OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028
Philips Medical Systems Nederlands
Class I - Dangerous
The fixation of the upper and lower tilt actuator, of the Omnidiagnost system might break off and the table will start to rotate from 0 to + 90 /- 90 degree with high speed. This rotating movement can not be stopped by the user. This could potentially lead to the patient falling off the table. There is a risk of injury for the patient, user, or bystander.
OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025
Philips Medical Systems Nederlands
Class I - Dangerous
The fixation of the upper and lower tilt actuator, of the Omnidiagnost system might break off and the table will start to rotate from 0 to + 90 /- 90 degree with high speed. This rotating movement can not be stopped by the user. This could potentially lead to the patient falling off the table. There is a risk of injury for the patient, user, or bystander.
The dose calculation accuracy may in some situations be less than expected. The user must be aware in order to avoid incorrect dose calculations during treatment planning.
Class I - Dangerous
Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.
Potential for the display processor to experience an unexpected failure.