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K-2 KARE-ZONE
KAP MEDICAL · Model K-2SM-EU-XMS · UDI-DI 00817012024913
10
510(k) clearances
2,524
Adverse events (154 deaths)
13
Recalls
127
Facilities
Description
Auto Immerssion, Alternating Pressure with On-Demand Low Air Loss 36"~42"~48" Wide, 80"~85"~90" Long Expandable Mattress, Bariatric EU System
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-01-21 | Agiliti Health - Ellis | Agiliti identified an issue where the Adapt Pump (61600200-Adapt Pump) supplied with all Adapt Line support surfaces does not re-engage the Microclimate Management function after u |
| 2025-10-31 | Stryker Medical Division of Stryker Corporation | Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential inten |
| 2023-11-01 | Turncare, Inc | A software issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy. |
| 2023-08-10 | Turncare, Inc | A software update corrected an issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running p |
| 2021-04-15 | Getinge (Suzhou) Co Ltd | There is a potential for abnormal inflation of the mattress. |
| 2016-07-11 | American National Mfg Inc | The Panacea Air Pro Mattress Control Unit is being recalled due to a firmware problem, which may result in the device not having the firmness range required. |
| 2015-12-03 | Stryker Medical Division of Stryker Corporation | Potential for power cord to melt; hazards include electric shock and fire. |
| 2014-03-18 | SCM True Air Technologies LLC | The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors. |
| 2010-03-05 | Encompass Therapeutic Support Systems dba BG North America | Potential out gasing of the battery and short term ignition of the gas within the control unit enclosure. This failure mode includes a risk for fire. |
| 2008-10-09 | Hill-Rom Manufacturing, Inc. | These devices have the potential to overheat. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.