Recall Z-1216-2015— Arjo Hospital Equipment AB
Class II · Terminated
Class II FDA medical device recall by Arjo Hospital Equipment AB, initiated 2014-12-03, terminated 2015-10-30. FDA's recall record names no specific 510(k) clearance for this event. Product: RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.. Reason: The recalled devices labeling and instructions for use contain unapproved medical claims..
- Recalling firm
- Arjo Hospital Equipment AB
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-03
- Terminated
- 2015-10-30
- Firm location
- Malm¿, N/A, Sweden
Product description
RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.
Reason for recall
The recalled devices labeling and instructions for use contain unapproved medical claims.
Data sourced from openFDA. This site is unofficial and independent of the FDA.