St Jude Medical recalls WorkMate Claris v1.2 Upgrade Kits (model H800007, H800012) due to software errors that may cause screen blackouts or system failure. No action required as the issue is not dangerous.
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
St Jude Medical is recalling WorkMate Claris v1.2 Upgrade Kits with model numbers H800007 and H800012 because a software error could cause the system to lose functionality or the screen to turn black during use. This recall does not pose a safety risk to users.
A software error in the v1.2 Upgrade Kits can cause the system to lose functionality or the screen to turn black during operation. This issue does not involve physical harm or safety risks but may affect device performance.
Users of WorkMate Claris v1.2 Upgrade Kits with model numbers H800007 or H800012 are affected. Medical device users are most at risk if the software error impacts their system operation.
Check for WorkMate Claris v1.2 Upgrade Kits with model numbers H800007 or H800012. The recall applies to none of the products sold, as stated in the record.
Verify the model number on your WorkMate Claris v1.2 Upgrade Kit to confirm if it is H800007 or H800012.
No, the recall is for potential software issues that may cause screen blackouts or system failure but does not pose a safety risk.
The recall does not require any action as the issue is not dangerous and the products are not at risk of causing injury.
Model numbers H800007 and H800012 for WorkMate Claris v1.2 Upgrade Kits.
We’ve drafted a message you can send St Jude Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1855-2021 — St Jude Medical St Jude Medical Hello, I own a St Jude Medical that is covered by recall Z-1855-2021 from St Jude Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.