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Health Canada Medical devices

Digital Diagnost C90

Issued June 13, 2022
Issue
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
Hazard description
Performance
Product
Product name
Digital Diagnost C90
Reference
ID
RA-64252