KCI recalls ACTIV.A.C Therapy System models from 2007-2020 with software up to 3.11 due to risk of stopping negative pressure wound therapy without user notification.
The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy.
KCI is recalling ACTIV.A.C Therapy Systems made between 2007 and 2020 with software versions up to 3.11. The device may power off without warning, which could stop wound healing treatment for open wounds.
The device may power off without notifying the user, causing a stoppage of negative pressure wound therapy. This could interrupt the healing process for open wounds by preventing the removal of exudate and infectious material.
Patients using the ACTIV.A.C Therapy System for open wounds are affected. Those with wounds requiring negative pressure therapy are most at risk.
Check for model numbers listed in the recall: US 340000 ACTIV.A.C., or other regional variants like UK 340001, Australian 340003, and others. Products were made from 2007 to 2020 with software versions up to 3.11.
Identify your ACTIV.A.C model number by checking the product label or documentation.
Reach out to KCI USA, INC. for assistance with the recall process.
The device may power off without notifying the user, which could stop negative pressure wound therapy and interrupt wound healing.
Models produced from 2007 to 2020 with software versions up to 3.11, including US 340000 ACTIV.A.C. and regional variants like UK 340001.
No, but you should check if your device is affected and contact KCI if needed.
We’ve drafted a message you can send KCI to request your refund or repair — edit it as you like.
Subject: Recall Z-2542-2020 — KCI KCI Hello, I own a KCI that is covered by recall Z-2542-2020 from KCI. 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.
