GE Healthcare SIGNA Voyager nuclear magnetic resonance imaging system recall — FDA Z-0138-2022
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
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Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Product has a lack of sterility assurance
Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.
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…
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
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.…
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
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…
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…
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Due to misbranded products shipped to customers.
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
The labeling was missing information on sterilization and prohibition of reuse.
Due to misbranded products shipped to customers.
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.
There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
Potential for mallet head to become separated from mallet handle. There is also significant deformations on striking surface that were not expected
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
The milk pasteurization temperature was not recorded and/or the air space temperature was not at 150F or above as required.
Inspection by the California Department of Public Health found undeclared allergens in numerous bakery products.
Inspection by the California Department of Public Health found undeclared allergens in numerous bakery products.
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