Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and preventi
FDA device recall Z-1217-2015 · posted 2015-02-27 · Terminated
Recall details
- Recalling firm
- Arjo Hospital Equipment AB
- Reason for recall
- The recalled devices labeling and instructions for use contain unapproved medical claims.
- Action taken
- 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.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- IKZ
- Quantity affected
- 226 units
- Distribution
- Worldwide Distribution. US nationwide, Germany, Austria, France, Italy, India, EU, Mexico, Switzerland, Canada, Saudi Arabia, Kuwait, Middle East, China, Japan, and Qatar.
- Date initiated
- 2014-12-03
- Date posted
- 2015-02-27
- Date terminated
- 2015-10-30
- Location
- Malm¿, Sweden
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