1 Series Phototherapy Device
Brand(s)
Last updated
Summary
Product
1 Series Phototherapy Device
Issue
Medical devices - Performance issue
What to do
MANUFACTURER HAS AUTHORIZED USERS TO RETURN THE AFFECTED DEVICES FOR A SOFTWARE UPDATE.
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| 1 Series Phototherapy Device | OS22871PLNBCX0004 OS22612PLNBCX0004 OS22873PLNBCX0004 OS22201PLNBCX0004 OS22334PLNBCX0004 OS23086PLNBCX0004 OS23189PLNBCX0004 OS24421PLNBCX0004 OS22303PLNBCX0004 | 807OS0004CX6 |
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies
Daavlin Distributing Company
205 West Bement St., Bryan, Ohio, United States, 43506
Published by
Health Canada
Audience
General public
Recall class
Type II
Identification number
RA-64238
Get notified
Receive notifications for new and updated recalls and alerts by category.