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Terminated

Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.

FDA Recall Z-1217-2015 · Posted 2015-02-27

Recalling FirmArjo Hospital Equipment AB
Recall StatusTerminated
Product CodeIKZ
Date Initiated2014-12-03
Date Terminated2015-10-30
Product Quantity226 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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