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Artis Pheno X-Ray System (Siemens) – Hardware Issue (2022)

Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.

Moderate

FDAAug 10, 2022Nationwide• Siemens Medical Solutions USA, Inc

Artis Q X-Ray System (Siemens) – Hardware Issue (2022)

Moderate

FDAAug 10, 2022Nationwide• Siemens Medical Solutions USA, Inc

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Artis Pheno X-Ray System (Siemens) – Hardware Issue (2022)

Artis Q X-Ray System (Siemens) – Hardware Issue (2022)

VenaCure EVLT Kit (Angiodynamics) – Fiber Dimension Problem (2022)

Colgate Stain Fighter Toothpaste (Family Dollar) – Temperature Deviation (2022)

Colgate Charcoal Toothpaste (Family Dollar) – Temperature Deviation (2022)

Colgate Anticavity Toothpaste (Family Dollar) – Temperature Deviation (2022)

Colgate Whitening Mouthwash (Family Dollar) – Temperature Deviation (2022)

Colgate Advanced Toothpaste (Family Dollar) – Temperature Deviation (2022)

Colgate Pro Series Toothpaste (Family Dollar) – Temperature Deviation (2022)

Dewei DNA/RNA Kit (Unknown) – FDA Authorization (2022)

COVID-19 Ag Test (Jiangsu Well) – Unauthorized Distribution (2022)

BioZorb LP Marker (Hologic) – Expiration Label (2022)

Boston Scientific Guider Softip (Boston Scientific) – Tip Curve Mismatch (2022)

PDS II Suture (Ethicon) – Material Error (2022)

Stryker USB Converter (Mako) – Potential Failure (2022)

CoViPoint COVID Test (GS Biomark) – FDA Authorization (2022)

Timolol Maleate Eye Solution (Akorn) – Unknown Impurity (2022)

Sensation Insertion Kit (Datascope) – Dilator Size (2022)

MEGA Intra-Aortic Balloon (Datascope) – Dilator Size (2022)

LINEAR IAB (Datascope) – Volume Labeling (2022)