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Somatom definition edge

Official notice

19 Nov 2021

Last checked

19 Nov 2021

Medium riskHealth Canada

An official Health Canada notice concerns Somatom definition edge. Sporadic problems with the current software may result in workflow interruptions. (With software versions Syngo.CT VB20 or VB20 SP1 or VB20 SP2 or VB20 SP3 or VB20 SP4.) Recall start date: 2021-11-08 Published 2021-11-19.

What to do now

Contact the manufacturer if you require additional information.

Recall number

63637

Official notice

2021-11-19

The hazard

Sporadic problems with the current software may result in workflow interruptions. (With software versions Syngo.CT VB20 or VB20 SP1 or VB20 SP2 or VB20 SP3 or VB20 SP4.) Recall start date: 2021-11-08

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

63637

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Affected products

Product 1

Affected Products - SOMATOM DEFINITION AS - MAIN UNIT, Lot or serial number - ALL WITH INITIAL RELEASE VB20, Model or catalog number - 8098027

Product 2

Affected Products - SOMATOM DEFINITION FLASH SYS - MAIN, Lot or serial number - ALL WITH INITIAL RELEASE VB20, Model or catalog number - 10430603

Product 3

Affected Products - SOMATOM DEFINITION EDGE SYSTEM - CT SYSTEM, Lot or serial number - ALL WITH INITIAL RELEASE VB20, Model or catalog number - 10590000

Product 4

Affected Products - SOMATOM FORCE, Lot or serial number - ALL WITH INITIAL RELEASE VB20, Model or catalog number - 10742326

Product 5

Affected Products - SOMATOM DRIVE, Lot or serial number - ALL WITH INITIAL RELEASE VB20, Model or catalog number - 10431700

Product 6

Affected Products - SOMATOM CONFIDENCE - SYSTEM, Lot or serial number - ALL WITH INITIAL RELEASE VB20, Model or catalog number - 10590100

Product 7

Affected Products - SOMATOM EDGE PLUS, Lot or serial number - ALL WITH INITIAL RELEASE VB20, Model or catalog number - 10267000

Risk / hazard

Sporadic problems with the current software may result in workflow interruptions. (With software versions Syngo.CT VB20 or VB20 SP1 or VB20 SP2 or VB20 SP3 or VB20 SP4.) Recall start date: 2021-11-08

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, Somatom Definition Edge.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

63637

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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