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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
An incorrect center bolt was used in the assembly of the product which could result in a patient fall during use.
Transport company failed to stop at the border for required FDA inspection.
Potential for false positive results for SARS-CoV-2 in identified lots of cartridges, when used in conjunction with assays containing SARS-CoV-2 targets (NeuMoDx" SARS-CoV-2 Test Strip Cat #300800 and NeuMoDx" Flu A-B/RSV/SARS-CoV-2 Vantage Assay Cat #300900) result incorrect management of patients
Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of the locking mechanism causing the Transport Guard to not open or, if the locking pin is fully disengaged from the assembly, a full disassembly of the Transport Guard may occur, resulting in a delay of support if a product exchange is necessary.
There is potential for the images to be flipped left to right.
There is potential for the images to be flipped left to right.
Evaporation of stabilizing liquid reducing shelf life.
There is potential for the images to be flipped left to right.
There is potential for the images to be flipped left to right.
Potential exposure to rodents and rodent activity in the distribution center.
Evaporation of stabilizing liquid reducing shelf life.
IRISpec CA failures for glucose.
Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.
The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is likely to observe an increase in false-positive or indeterminate results.
When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an operator manually modified the range during a pause, there is a risk that a portion of the treatment beam after the resume is delivered with an error in range
Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.
Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.
While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.
While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.
Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system.