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Lower risk Medical device recall · FDA · Published May 5, 2021

St Jude Medical WorkMate Claris Display Software Error May Cause Screen Blackout

St Jude Medical recalls WorkMate Claris System Display Model H700124 with v.1.2 software upgrade that may cause screen blackouts during use. Affected units include specific serial numbers listed in the recall.

🇺🇸 FDA recall #Z-1854-2021Medical deviceSt Jude Medical ›
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Contact the company

Recalling firmAbbott Laboratories Inc. (St Jude Medical)1 Saint Jude Medical Dr · Saint Paul, MN 55117-1789
✎ GovInfoNow plain-language explainer

What happened, in plain English

St Jude Medical is recalling WorkMate Claris System Display Model H700124 units that have a v.1.2 software upgrade installed. This recall is because the software error can cause the screen to turn black during operation, potentially making the device unusable. Read more at govinfonow.com/recall/62601-st-jude-medical-workmate-claris-display-software-error-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/62601-st-jude-medical-workmate-claris-display-software-error-may-cause · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1854-2021

Cite this page

“St Jude Medical WorkMate Claris Display Software Error May Cause Screen Blackout.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62601-st-jude-medical-workmate-claris-display-software-error-may-cause. Based on FDA recall #Z-1854-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1854-2021%22&limit=1).

Why it’s dangerous

The software error in the v.1.2 upgrade can cause the display screen to turn black during operation. This may lead to loss of functionality in the cardiac monitoring system, but it does not cause physical harm to users.

Who’s affected

Healthcare professionals using the WorkMate Claris System Display for cardiac monitoring are most at risk. The recall affects specific units with the model number H700124 and listed serial numbers.

How to tell if you have this one

Check if your WorkMate Claris System Display has the model number H700124 and the v.1.2 software upgrade installed. Affected units have specific serial numbers listed in the recall notice.

  • Brand
    St Jude Medical
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    US Nationwide distribution in the states of MI, KS, MO, TX.
Recall numberProduct, codes & lotsQuantity
Z-1853-2021v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies.; Serial Numbers: 14399319, 15508962, 18782712, 188558564 units
Z-1854-2021v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies.; Serial Numbers: 14774202, 14779111, 15812169, 15812170, 18243196, 18243205, 18643643, 18782716, 189179269 units
Z-1855-2021WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012; None8 units
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify if your WorkMate Claris System Display has the v.1.2 software upgrade installed by checking the device settings.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 4 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: named in the noticeMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “US Nationwide distribution in the states of MI, KS, MO, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Kansas, Michigan, Missouri, Texas.

Recall timeline

FDA terminated this recall 3.1 years after the firm started it.

1. Firm started the recall: May 5, 202112. FDA classified it Class II: Jun 14, 202123. Published in FDA’s Enforcement Report: Jun 23, 202134. FDA terminated the recall: Jun 18, 2024420212024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1854-2021 (May 5, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1854-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA