FDA Devices recall · Reported March 11, 2015
RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.
The recalled devices labeling and instructions for use contain unapproved medical claims.
Arjo Hospital Equipment Ab recalled RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy Sy… - a moderate-severity action.
RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy Sy… was recalled by Arjo Hospital Equipment Ab in March 11, 2015. Reason: The recalled devices labeling and instructions for use contain unapproved medical claims.. Check the official notice for the remedy. Verify recall #Z-1216-2015 with the FDA Devices before acting.
The recall
Arjo Hospital Equipment Ab issued this moderate-severity FDA Devices recall-The recalled devices labeling and instructions for use contain unapproved medical claims..
- Moderate
- severity level
- 271 units
- affected scope
- Class II
- classification
- March 11, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1216-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1216-2015) was formally reported on March 11, 2015, with the manufacturer initiating the action on December 3, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Arjo Hospital Equipment Ab is listed as the recalling firm, operating out of Malm¿, N/A. Federal records list the affected scope as 271 units.
The documented reason for this recall is: The recalled devices labeling and instructions for use contain unapproved medical claims. Distribution data in the federal record shows the product reached: Worldwide Distribution. US nationwide, Germany, Austria, France, Italy, India, EU, Mexico, Switzerland, Canada, Saudi Arabia, Kuwait, Middle East, China, Japan, and Qatar.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1216-2015 |
| Date reported | March 11, 2015 |
| Date initiated | December 3, 2014 |
| Recalling firm | Arjo Hospital Equipment Ab |
| Firm location | Malm¿, N/A |
| Affected scope | 271 units |
| Distribution | Worldwide Distribution. US nationwide, Germany, Austria, France, Italy, India, EU, Mexico, Switzerland, Canada, Saudi Arabia, Kuwait, Middle East, China, Japan, and Qatar. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1216-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026