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Mammomat revelation

Official notice

11 May 2023

MediumHealth Canada

An official Health Canada notice concerns Mammomat revelation. The new software version VC20G provides latest cybersecurity updates and improvements in the following categories: - Improves overall system stability - Improves dicom connectivity - Improves biopsy workflow Specifically, the new software version updates some d icom tags related to pre-fix for spot images and spatial locations preserved. It eliminates lock conflict during tomosynthesis reconstruction and detector connection issues. Updated user messages provide clear guidance during the biopsy procedure. Recall start date: May 2, 2023 Published 2023-05-11.

What to do now

Contact the manufacturer if you require additional information.

Recall number

73643

Official notice

2023-05-11

The hazard

The new software version VC20G provides latest cybersecurity updates and improvements in the following categories: - Improves overall system stability - Improves dicom connectivity - Improves biopsy workflow Specifically, the new software version updates some d icom tags related to pre-fix for spot images and spatial locations preserved. It eliminates lock conflict during tomosynthesis reconstruction and detector connection issues. Updated user messages provide clear guidance during the biopsy procedure. Recall start date: May 2, 2023

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

73643

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Affected products

Product 1

Affected products - Mammomat Revelation, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 11343300

Risk / hazard

The new software version VC20G provides latest cybersecurity updates and improvements in the following categories: - Improves overall system stability - Improves dicom connectivity - Improves biopsy workflow Specifically, the new software version updates some d icom tags related to pre-fix for spot images and spatial locations preserved. It eliminates lock conflict during tomosynthesis reconstruction and detector connection issues. Updated user messages provide clear guidance during the biopsy procedure. Recall start date: May 2, 2023

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Siemens, Mammomat Revelation.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

73643

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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