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1 Series phototherapy device

Official notice

7 Jun 2022

Last checked

7 Jun 2022

Medium riskHealth Canada

An official Health Canada notice concerns 1 Series phototherapy device. 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 Published 2022-06-07.

What to do now

Manufacturer has authorized users to return the affected devices for a software update.

Recall number

64238

Official notice

2022-06-07

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

64238

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Affected products

Product 1

Affected products - 1 Series Phototherapy Device, Lot or serial number - OS22871PLNBCX0004 OS22612PLNBCX0004 OS22873PLNBCX0004 OS22201PLNBCX0004 OS22334PLNBCX0004 OS23086PLNBCX0004 OS23189PLNBCX0004 OS24421PLNBCX0004 OS22303PLNBCX0004, Model or catalog number - 807OS0004CX6

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Daavlin Distributing, 1 Series Phototherapy Device.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

64238

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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