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Synapse picture archiving and communications systems

Official notice

15 Feb 2024

Last checked

15 Feb 2024

Medium riskHealth Canada

An official Health Canada notice concerns Synapse picture archiving and communications systems. Fujifilm has become aware that measurements on a secondary capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a breast tomo series results in incorrect measurements. This issue affects Synapse PACS - versions 7.1.x, 7.2x and 7.3.0x. There have been no reported patient injuries associated with these issues. Recall start date: January 30, 2024 Published 2024-02-15.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75074

Official notice

2024-02-15

The hazard

Fujifilm has become aware that measurements on a secondary capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a breast tomo series results in incorrect measurements. This issue affects Synapse PACS - versions 7.1.x, 7.2x and 7.3.0x. There have been no reported patient injuries associated with these issues. Recall start date: January 30, 2024

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

75074

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Affected products

Product 1

Affected products - Synapse Picture Archiving And Communications Systems, Lot or serial number - contact CHRISTIE INNOMED INC., Model or catalogue number - SYNAPSE PACS VERSION 7.1.X SYNAPSE PACS VERSION 7.2.X SYNAPSE PACS VERSION 7.3.0X SYNAPSE PACS

Risk / hazard

Fujifilm has become aware that measurements on a secondary capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a breast tomo series results in incorrect measurements. This issue affects Synapse PACS - versions 7.1.x, 7.2x and 7.3.0x. There have been no reported patient injuries associated with these issues. Recall start date: January 30, 2024

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: Fujifilm, Synapse Picture Archiving And Communications.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

75074

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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