Recall Z-1217-2015— 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: Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention 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
Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention 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.