KCI USA, INC.: ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008188 - Product Usage: is an integrated wound management system for use in the acute, extended, and home care settings. When used on open wounds, it is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

Recall number

Z-2542-2020

Recalling firm

KCI USA, INC.

Product

ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008188 - Product Usage: is an integrated wound management system for use in the acute, extended, and home care settings. When used on open wounds, it is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

Status

Terminated

Initiated

2020-06-08

Posted

not on file

Terminated

2023-02-07

Reason

The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy.

Root cause

Under Investigation by firm

Action

For Customer Owned units, KCI plans to notify customers via customer letters delivered by common carriers or via email communication that the ACTIV.A.C." Therapy Unit may shut down without notification to the user. The customer letter notification or email communication will inform customers to coordinate the product software change. The recalling firm sent an URGENT - MEDICAL DEVICE RECALL letter to the affected customers on 06/08/2020. The completed Customer Response Form is to be returned to kci3mfieldactionresponse@mmm.com

Quantity

5,823 units

Distribution

Worldwide distribution - US Nationwide distribution including in the states of AZ, FL, IL, OH, MD, ND, NV, OK, SC, TN, TX, UT, VA, WA and Puerto Rico. The country of Australia, Austria, Canada, China, France, Germany, Japan, Hong Kong, India, Indonesia, Malaysia, New Zealand, Philippines, South Korea, Sri Lanka, Switzerland, Taiwan, Thailand, United Kingdom and Vietnam.

Lot, serial or model codes

Products produced from 2007 to 2020 (with software versions up to 3.11)  All serial numbers affected for the following model numbers:  US: 340000 ACTIV.A.C., NORTH AMERICAN RTMGSM01/US ACTIVAC - RTM, NORTH AMERICAN Outside: 340001 ACTIV.A.C., UNITED KINGDOM  340003 ACTIV.A.C., AUSTRALIAN  340004 ACTIV.A.C., SPANISH  340005 ACTIV.A.C., GERMAN  340006 ACTIV.A.C., FRENCH  340007 ACTIV.A.C., ITALIAN  340008 ACTIV.A.C., DUTCH  340009 ACTIV.A.C., DANISH  340010 ACTIV.A.C., SWEDISH  340012 ACTIV.A.C., JAPAN 340013 ACTIV.A.C., CANADIAN  340015 ACTIV.A.C., TURKEY  340123 ACTIV.A.C., INDIA  340356 ACTIV.A.C., BRAZIL 415311 ACTIV.A.C., CZECH 415312 ACTIV.A.C., HUNGARIAN 415313 ACTIV.A.C., SLOVAKIAN 415314 ACTIV.A.C., CROATIAN 415315 ACTIV.A.C., POLAND 415316 ACTIV.A.C., SLOVENIA 415317 ACTIV.A.C., SOUTH AFRICA 416008 ACTIV.A.C., INDONESIA 416162 ACTIV.A.C., CHINA 416564 ACTIV.A.C., PHILIPPINES 416599 ACTIV.A.C., EUROPEAN UNION

510(k) numbers

["K183543"]

PMA numbers

not on file

Product code

OMP

Firm FEI

3009897021

Firm city

San Antonio

Firm state

TX

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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