Health product recall

Digital Diagnost C90

Last updated

Summary

Product
Digital Diagnost C90
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

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

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

Philips Medical Systems DMC GmbH

Roentgenstrasse 24, Hamburg, Germany, 22335

Published by
Health Canada
Audience
Healthcare
Recall class
Type III
Identification number
RA-64252

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