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K-Z Z-TURN
KAP MEDICAL · Model K-ZM-UK-MS · UDI-DI 00817012028362
10
510(k) clearances
817
Adverse events (30 deaths)
12
Recalls
21
Facilities
Description
Auto Immerssion, Alternating Rotation, Pulsation, with True Low Air Loss 10" High Mattress, Standard 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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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.