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Digital diagnost c90
Official notice
13 Jun 2022
Last checked
13 Jun 2022
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
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
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.
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Philips, Digital Diagnost C90.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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