Medical Devices Recalls

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

The belt may fail at lower loads than the labeled 600lbs.

A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime requirement per Getinge internal Product Specification. These nonconforming batteries were inadvertently released to customers.

Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.

A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the diagnostic imaging system failing resulting in rescanning and reinjection of contrast medium.

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unresponsive system, necessitating system restart, which could lead to therapy/treatment delay and/or unnecessary therapy/treatment. Can occur during ultrasound-guided TEE with EchoNavigator, if secondary screen capture is enabled and user presses other system buttons before secondary capture completed.

Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.

Product has a lack of sterility assurance

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date.

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.

There was an increase in complaints related to tip breaks and wobble/vibration.

Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days

There was an increase in complaints related to tip breaks and wobble/vibration.