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Health Canada Medical devices

1 Series Phototherapy Device

Issued June 7, 2022
Issue
Software update required. a change was made to v3.00 (released june 30, 2021) to update bit11 in HST file flag. This was done for compatibility with clearlink website- discovered 0inch/9inch inconsistency when testing for Arcutis clinical trial data migration. Release versions prior to v3.00 did not have this functional issue. Recall start date: June 6, 2022
Hazard description
Performance
Product
Product name
1 Series Phototherapy Device
Reference
ID
RA-64238