Elekta MOSAIQ Oncology Information System recall — FDA Z-2406-2026
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
1,218 detailed records are currently available in this category.
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Reusable electrodes may not meet expected performance levels.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock…
Due to incorrect incubation process being performed on product.
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may…
Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock…
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.
Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may…
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and contains different first aid instructions, most…
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may…
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock…
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the…
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the…
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