Product Wiki · Recalls · Health Canada — Medical Devices

1 Series Phototherapy Device — recall 64238

Health Canada — Medical Devices · Canada · 2022-06-07 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
64238
Date of alert
2022-06-07
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
General and plastic surgery
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/1-series-phototherapy-device

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