SIGNA Pioneer nuclear magnetic resonance imaging system
GE Healthcare
Class I - Dangerous
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
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Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
Class I - Dangerous
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Class I - Dangerous
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Class I - Dangerous
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Class I - Dangerous
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Canon Medical System, USA
Class I - Dangerous
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.
Class I - Dangerous
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Philips Ultrasound
Class I - Dangerous
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.
SIGNA Voyager nuclear magnetic resonance imaging system
GE Healthcare
Class I - Dangerous
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
SIGNA Artist nuclear magnetic resonance imaging system
GE Healthcare
Class I - Dangerous
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Class I - Dangerous
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results
HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma Part Number: 0020302602
Instrumentation Laboratory
Class I - Dangerous
Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
SIGNA Premier nuclear magnetic resonance imaging system
GE Healthcare
Class I - Dangerous
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Abbott Molecular
Class I - Dangerous
There is a potential for false positive results.
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Roche Molecular Systems
Class I - Dangerous
False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Abbott Molecular
Class I - Dangerous
There is a potential for false positive results.
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Abbott Molecular
Class I - Dangerous
There is a potential for false positive results.
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Abbott Molecular
Class I - Dangerous
There is a potential for false positive results.
Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Abbott Molecular
Class I - Dangerous
There is a potential for false positive results.