Home › Device types › IKZ
Bed, Patient Rotation, Powered
FDA product code IKZ · Class 2 · Physical Medicine
358
Registered devices
817
Adverse events
12
Recalls
17
510(k) clearances
Devices with this code
K-ZZM ZMatt — KAP MEDICALAirisana — Encompass Group, L.L.C.Hill-Rom — Tridien MedicalK-6oem AIRE-TURN ASSIST — KAP MEDICALK-6oem AIRE-TURN ASSIST — KAP MEDICALHill-Rom — Tridien MedicalK-Z Z-TURN — KAP MEDICALK-Zoem EZ-TURN — KAP MEDICALK-6 TURN-ZONE — KAP MEDICALK-Z Z-TURN — KAP MEDICALHill-Rom — Tridien MedicalK-6oem AIRE-TURN ASSIST — KAP MEDICALHill-Rom — Tridien MedicalHill-Rom — Tridien MedicalHill-Rom — Tridien MedicalHill-Rom — Tridien MedicalK-6 TURN-ZONE — KAP MEDICALK-6 TURN-ZONE — KAP MEDICALSenTech — Tridien MedicalK-Zoem EZ-TURN — KAP MEDICALK-6 TURN-ZONE — KAP MEDICALK-Z Z-TURN — KAP MEDICALK-6oem AIRE-TURN — KAP MEDICALAirisana — Encompass Group, L.L.C.
Recent 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 labe |
| 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 tur |
| 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 pati |
| 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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