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Centricity pacs system

Official notice

30 Aug 2024

Last checked

30 Aug 2024

Critical riskHealth Canada

An official Health Canada notice concerns Centricity pacs system. GE Healthcare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers (Ckeys). If this occurs, it can result in acquisition of a partial study. In an unlikely scenario that the partial study is unnoticed, it can lead to misdiagnosis. Centricity PACS is able to uniquely identify approximately 2.1 billion images (e.g. Equivalent to 21 million exams with 100 images each). However, there is no notification to the user when the maximum number of unique image identifiers has been reached. Recall Start Date: August 22, 2024 Published 2024-08-30.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75994

Official notice

2024-08-30

The hazard

GE Healthcare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers (Ckeys). If this occurs, it can result in acquisition of a partial study. In an unlikely scenario that the partial study is unnoticed, it can lead to misdiagnosis. Centricity PACS is able to uniquely identify approximately 2.1 billion images (e.g. Equivalent to 21 million exams with 100 images each). However, there is no notification to the user when the maximum number of unique image identifiers has been reached. Recall Start Date: August 22, 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

75994

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Affected products

Product 1

Affected products - Centricity PACS System, Lot or serial number - Centricity PAC V3 - ALL Centricity PAC V6 - ALL Centricity PAC V2 - ALL Centricity PAC V4 - ALL Centricity PAC V7 - ALL, Model or catalog number - K2033JT CENTRICITY PACS 3.1.1.1 00840682104807 K2024W 00840682145572 K2000YW

Risk / hazard

GE Healthcare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers (Ckeys). If this occurs, it can result in acquisition of a partial study. In an unlikely scenario that the partial study is unnoticed, it can lead to misdiagnosis. Centricity PACS is able to uniquely identify approximately 2.1 billion images (e.g. Equivalent to 21 million exams with 100 images each). However, there is no notification to the user when the maximum number of unique image identifiers has been reached. Recall Start Date: August 22, 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

Brand: GE Healthcare Iits Also Doing Business GE Healthcare, Centricity Pacs System.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

critical

Recall details

Recall number

75994

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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