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K-6oem AIRE-TURN ASSIST

KAP MEDICAL · Model K-6oem-UK-CON-B48 · UDI-DI 00817012028126

IKZ

510(k) clearances

817

Adverse events (30 deaths)

Recalls

Facilities

Description

Powered Convertible, Rotation,Alternating Pressure with On-Demand Low Air Loss 48" Wide Foam-Air Mattress, Bariatric UK System

Recalls

Date	Firm	Reason
2021-09-10	Kinsman Enterprises Inc	The belt may fail at lower loads than the labeled 600lbs.
2021-05-12	Stryker Medical Division of Stryker Corporation	Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately iden
2018-12-19	Arjohuntleigh Magog	Inability or difficulty in unbuckling/releasing the proning arm buckle might delay patient access in an emergency situation such as cardiac arrest. This, in turn, could contribute
2014-12-03	Arjo Hospital Equipment AB	The recalled devices labeling and instructions for use contain unapproved medical claims.
2014-12-03	Arjo Hospital Equipment AB	The recalled devices labeling and instructions for use contain unapproved medical claims.
2014-12-03	Arjo Hospital Equipment AB	The recalled devices labeling and instructions for use contain unapproved medical claims.
2013-09-11	ArjoHuntleigh Inc.	The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient
2011-02-18	KCI USA, Inc.	Buckles used to secure patient to surface during proning therapy can come open if not properly engaged by user.
2010-09-09	KCI USA, Inc.	Product complaints indicating that while attempting to resolve an alarm or error condition, operator was unable to return product to the prone position for patient.
2005-01-24	Kinetic Concepts, Inc	To correct software issues in software versions 1.3 and 1.5 and to upgrade hatch latch handles to a more ergonomic design.

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Data 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.