Loading...
Loading...
Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.
A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing, and if a malfunction occurs, therefore the device could fail to deliver therapy.
Due to an increase in complaints of door latch assembly failures that may cause the doors to be left in an open state potentially causing inventory discrepancies, a delay in access to medication and/or diversion of medication.
There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
Automated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier version of drawer firmware during new device installations or device replacement upgrades, which may lead to an increased frequency of drawer failures, which could increase the likelihood of patients experiencing delays in receiving medications.
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.
The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.
Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.
It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source required for embryo culture and development.
Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result in inflammation, infection, sepsis, or ischemia.
Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked, swelling, too hot to hold, it will no longer hold charge, or it fails Reader Test. Do not use other chargers. User Manual update includes instructions on reader safe storage, charging, use.
Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked, swelling, too hot to hold, it will no longer hold charge, or it fails Reader Test. Do not use other chargers. User Manual update includes instructions on reader safe storage, charging, use.
Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.