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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89990

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 26, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Daavlin Distributing Company

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. Models: [1 Ser CX 305-4 120-240V 50/60Hz, item # 06OS0004CX6], [1 Ser CX 311-4 120-240V 50/60Hz CE, item # 807OS0004CX5], [1 Ser CX 311-4 120-240V 50/60Hz, item # 807OS0004CX6], [1 Ser CX 350-4 120-240V 50/60Hz, item # 807OS0400CX6], [1 Ser CX UVA1-4 120-240V 50/60Hz, item # 807OS0400CX6A1]

Z-1073-2022
Recall number
Z-1073-2022
Initiated
April 26, 2022
Classification
Class II
Status
Ongoing
Quantity
216

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software issue

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing.

Code information

UDI-DI: +B2809806OS0004CX60K, +B2809807OS0004CX50K, +B2809807OS0004CX60L, +B2809807OS0400CX60L, and +B2809807OS0400CX6A10W. Serial Numbers: OS22183PLNBCX0004, OS22320PLNBCX0004, OS23725PLNBCX0004, OS24083PLNBCX0004, OS24089PLNBCX0004, OS24090PLNBCX0004, OS23532PLA1CX0400, OS22097PLNBCX0004, OS22200PLNBCX0004, OS22265PLNBCX0004, OS22270PLNBCX0004, OS22304PLNBCX0004, OS22739PLNBCX0004, OS22788PLNBCX0004, OS22795PLNBCX0004, OS23239PLNBCX0004, OS23609PLNBCX0004, OS23894PLNBCX0004, OS24017PLNBCX0004, OS24254PLNBCX0004, OS24810PLNBCX0004, OS21997PLNBCX0004, OS22060PLNBCX0004, OS22063PLNBCX0004, OS22273PLNBCX0004, OS22309PLNBCX0004, OS22637PLNBCX0004, OS22680PLNBCX0004, OS22736PLNBCX0004, OS22738PLNBCX0004, OS22770PLNBCX0004, OS22789PLNBCX0004, OS22796PLNBCX0004, OS22919PLNBCX0004, OS22977PLNBCX0004, OS22980PLNBCX0004, OS22983PLNBCX0004, OS23244PLNBCX0004, OS23252PLNBCX0004, OS23440PLNBCX0004, OS23681PLNBCX0004, OS23724PLNBCX0004, OS23762PLNBCX0004, OS23855PLNBCX0004, OS23856PLNBCX0004, OS24008PLNBCX0004, OS24077PLNBCX0004, OS24104PLNBCX0004, OS24107PLNBCX0004, OS24109PLNBCX0004, OS24113PLACX0400, OS24127PLNBCX0004, OS24308PLNBCX0004, OS24310PLNBCX0004, OS24376PLNBCX0004, OS24467PLNBCX0004, OS24478PLNBCX0004, OS24229PLACX0400, OS22663PLNBCX0004, OS23940PLNBCX0004, OS23461PLNBCX0004, OS24829PLNBCX0004, OS22154PLNBCX0004, OS22112PLNBCX0004, OS22537PLNBCX0004, OS22271PLNBCX0004, OS24078PLNBCX0004, OS22227PLNBCX0004, OS23274PLNBCX0004, OS23481PLNBCX0004, OS23525PLNBCX0004, OS23676PLNBCX0004, OS23711PLNBCX0004, OS23910PLNBCX0004, OS24296PLNBCX0004, OS24325PLNBCX0004, OS24345PLNBCX0004, OS24358PLNBCX0004, OS24828PLNBCX0004, OS22794PLNBCX0004, OS24479PLNBCX0004, OS24682PLNBCX0004, OS24760PLNBCX0004, OS24228PLNBCX0004, OS24857PLNBCX0004, OS22033PLNBCX0004, OS22293PLNBCX0004, OS23526PLNBCX0004, OS23866PLNBCX0004, OS23896PLNBCX0004, OS24500PLNBCX0004, OS22439PLNBCX0004, OS22641PLNBCX0004, OS22766PLNBCX0004, OS23502PLNBCX0004, OS23941PLNBCX0004, OS24110PLNBCX0004, OS22015PLNBCX0004, OS22452PLNBCX0004, OS22453PLNBCX0004, OS24020PLNBCX0004, OS24680PLNBCX0004, OS22090PLNBCX0004, OS22266PLNBCX0004, OS22442PLNBCX0004, OS22633PLNBCX0004, OS22640PLNBCX0004, OS22764PLNBCX0004, OS23233PLNBCX0004, OS23255PLNBCX0004, OS23496PLNBCX0004, OS23527PLNBCX0004, OS23528PLNBCX0004, OS23873PLNBCX0004, OS23911PLNBCX0004, OS23961PLNBCX0004, OS24082PLNBCX0004, OS24105PLNBCX0004, OS24132PLNBCX0004, OS24211PLNBCX0004, OS22716PLACX0400, OS22717PLBBCX0004, OS23353PLACX0400, OS23354PLACX0400, OS23352PLACX0400, OS23355PLBBCX0004, OS22103PLACX0400, OS22062PLNBCX0004, OS22258PLNBCX0004, OS22229PLNBCX0004, OS22818PLNBCX0004, OS22869PLA1CX0400, OS23253PLNBCX0004, OS24051PLNBCX0004, OS24281PLNBCX0004, OS24422PLNBCX0004, OS24423PLNBCX0004, OS23183PLNBCX0004, OS22013PLNBCX0004, OS22049PLNBCX0004, OS22075PLNBCX0004, OS22088PLNBCX0004, OS22092PLNBCX0004, OS22106PLNBCX0004, OS22263PLNBCX0004, OS22269PLNBCX0004, OS22308PLNBCX0004, OS22397PLNBCX0004, OS22440PLNBCX0004, OS22441PLNBCX0004, OS22502PLA1CX0400, OS22635PLNBCX0004, OS22643PLNBCX0004, OS22681PLNBCX0004, OS22741PLNBCX0004, OS22762PLNBCX0004, OS22763PLNBCX0004, OS22765PLNBCX0004, OS22769PLNBCX0004, OS22791PLNBCX0004, OS22812PLNBCX0004, OS22822PLNBCX0004, OS22917PLNBCX0004, OS22918PLNBCX0004, OS23049PLNBCX0004, OS23053PLNBCX0004, OS23061PLNBCX0004, OS23101PLNBCX0004, OS23237PLNBCX0004, OS23240PLNBCX0004, OS23241PLNBCX0004, OS23243PLNBCX0004, OS23246PLNBCX0004, OS23254PLNBCX0004, OS23272PLNBCX0004, OS23418PLNBCX0004, OS23463PLNBCX0004, OS23466PLNBCX0004, OS23470PLNBCX0004, OS23474PLA1CX0400, OS23480PLNBCX0004, OS23529PLNBCX0004, OS23530PLNBCX0004, OS23569PLNBCX0004, OS23620PLNBCX0004, OS23675PLNBCX0004, OS23756PLNBCX0004, OS23857PLNBCX0004, OS23867PLNBCX0004, OS23890PLNBCX0004, OS23898PLNBCX0004, OS23909PLNBCX0004, OS24106PLNBCX0004, OS24166PLNBCX0004, OS24168PLA1CX0400, OS24227PLNBCX0004, OS24312PLNBCX0004, OS24539PLNBCX0004, OS24630PLNBCX0004, OS24743PLNBCX0004, OS24789PLNBCX0004, OS24791PLNBCX0004, OS24811PLNBCX0004, OS23940PLNBCX0004, OS22777PLNBCX0004, OS22778PLNBCX0004, OS20337PLNBCX0004, OS22201PLNBCX0004, OS22303PLNBCX0004, OS22334PLNBCX0004, OS22612PLNBCX0004, OS22871PLNBCX0004, OS22873PLNBCX0004, OS23086PLNBCX0004, OS23189PLNBCX0004, OS24421PLNBCX0004.

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, VA, WA, WI, WV and the countries of Australia, Canada.

device · product 2 of 2

4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. M4 Ser CX 311-20 120-240V 50/60Hz, item # 807QS0020CX6.

Z-1074-2022
Recall number
Z-1074-2022
Initiated
April 26, 2022
Classification
Class II
Status
Ongoing
Quantity
1

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software issue

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing.

Code information

UDI-DI: +B2809807QS0020CX60L. Serial Number: QS11571PLNBCX0020

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, VA, WA, WI, WV and the countries of Australia, Canada.