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Terminated

RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.

FDA Recall Z-1216-2015 · Posted 2015-02-27

Recalling FirmArjo Hospital Equipment AB
Recall StatusTerminated
Product CodeIKZ
Date Initiated2014-12-03
Date Terminated2015-10-30
Product Quantity271 units

Reason for Recall

The recalled devices labeling and instructions for use contain unapproved medical claims.

Firm 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.

Root Cause

Labeling design

Distribution Pattern

Worldwide Distribution. US nationwide, Germany, Austria, France, Italy, India, EU, Mexico, Switzerland, Canada, Saudi Arabia, Kuwait, Middle East, China, Japan, and Qatar.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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