Medical equipment, implants, and diagnostic devices
Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinterpret a patient as pre-menopausal when truly post- menopausal. This may lead to delayed initiation of a potentially beneficial drug and/or administration of an unnecessary drug in the treatment for hormone receptor positive advanced or metastatic breast cancer.
Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
The firm received one customer complaint concerning three OsteoSelect Demineralized Bone Matrix (DBM) devices which contained 5.0cc of putty, instead of 10.00cc of putty as labeled.
A software issue could potentially cause the stand and table movements to be blocked.
The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.
Philips North America
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
Custom surgical kits contain a plate different than indicated by the package labeling.
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.
Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.
A software issue could potentially cause the stand and table movements to be blocked.
Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Philips North America
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration.
Deroyal Industries, Inc. Lafollette
The sterile packaging has the potential to be compromised.
Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinterpret a patient as pre-menopausal when truly post- menopausal. This may lead to delayed initiation of a potentially beneficial drug and/or administration of an unnecessary drug in the treatment for hormone receptor positive advanced or metastatic breast cancer.
Siemens Medical Solutions USA
The Ysio system may process incorrect internal values for the position of its ceiling tube stand. If in this situation the user activates longitudinal or transversal stand movement (by using the buttons at the tube head or the remote console), the systems controls may (depending on the values being processed) initiate a correction of the tube stand position, resulting in an unexpected movement.