Infusion Pumps

Device lacks premarket approval.

The dosage information on the pouch is incorrect; the primary carton label is correct.

Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to the system following the incorrect deceleration profile, resulting in potential injury

Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the wrong isocenter which could result in serious patient injury

There is an error in the new version of the package insert. The Reading Table lists the incorrect color for a negative result for the CIT test.

Kit packaging may have small holes compromising product sterility

Kit packaging may have small holes compromising product sterility

Kit packaging may have small holes compromising product sterility

Kit packaging may have small holes compromising product sterility

Kit packaging may have small holes compromising product sterility

Kit packaging may have small holes compromising product sterility

Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. 2) Firm failing to register and list its medical devices with U.S. Food and Drug Administration.

Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay

Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.

Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.

Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. 2) Firm failing to register and list its medical devices with U.S. Food and Drug Administration.

The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.

There is a potential to display incomplete patient imaging study.

software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur

Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and 2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause elevated RPR reactivity potentially due to early shelf-life failure.