Recall Z-1216-2015 ยท IKZ Bed, Patient Rotation, Powered
Arjo Hospital Equipment AB
RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.
| Date | Feb 27, 2015 (initiated Dec 3, 2014) |
| Status | Terminated |
| Reason | The recalled devices labeling and instructions for use contain unapproved medical claims. |
| Root cause | Labeling design |
| Action | Devices in the rental fleet will be delivered to the customer with revised documents including the updated information. The customers who purchased the devices will be notified of the recall via letter sent by registered mail. The field correction notice will include a recall letter, response form, and updated labeling. |
| Quantity | 271 units |
| Distribution | Worldwide Distribution. US nationwide, Germany, Austria, France, Italy, India, EU, Mexico, Switzerland, Canada, Saudi Arabia, Kuwait, Middle East, China, Japan, and Qatar. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.