Health product recall

1 Series Phototherapy Device

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: 2022-06-10
Alert / recall type
Health product recall
Category
Health product - Medical device - 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