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Digital diagnost c90

Official notice

13 Jun 2022

Last checked

13 Jun 2022

Low riskHealth Canada

An official Health Canada notice concerns Digital diagnost c90. Operators may see an incorrect orientation of images during the first exam upon system start. Due to an issue in the firmware of the wallstand vs2 board, the system will rotate the amplimat field selection by 90 degrees. The anatomic position markers will become malpositioned and could potentially be associated with the opposite side of the anatomy. To date, Philips has not received reports of patient, user, or bystander harm in relation to these potential issues. Affected units are not required to be removed from service and are safe for continued use consistent with the device instructions for use and this medical device recall letter. Recall start date: June 2, 2022 Published 2022-06-13.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64252

Official notice

2022-06-13

The hazard

Operators may see an incorrect orientation of images during the first exam upon system start. Due to an issue in the firmware of the wallstand vs2 board, the system will rotate the amplimat field selection by 90 degrees. The anatomic position markers will become malpositioned and could potentially be associated with the opposite side of the anatomy. To date, Philips has not received reports of patient, user, or bystander harm in relation to these potential issues. Affected units are not required to be removed from service and are safe for continued use consistent with the device instructions for use and this medical device recall letter. Recall start date: June 2, 2022

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

64252

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Affected products

Product 1

Affected products - Digital Diagnost C90, Lot or serial number - Not applicable., Model or catalog number - 9890 010 83905

Risk / hazard

Operators may see an incorrect orientation of images during the first exam upon system start. Due to an issue in the firmware of the wallstand vs2 board, the system will rotate the amplimat field selection by 90 degrees. The anatomic position markers will become malpositioned and could potentially be associated with the opposite side of the anatomy. To date, Philips has not received reports of patient, user, or bystander harm in relation to these potential issues. Affected units are not required to be removed from service and are safe for continued use consistent with the device instructions for use and this medical device recall letter. Recall start date: June 2, 2022

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: Philips, Digital Diagnost C90.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type III

App estimate

low

Recall details

Recall number

64252

Classification

Type III

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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