RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and… — Class II medical device recall Z-0409-2013
Terminated recall by KCI USA, Inc., reported 2012-11-28, distributed nationwide. The firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy System head pack.
| Recall number | Z-0409-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | KCI USA, Inc., San Antonio, TX, United States |
| Recall initiated | 2012-06-27 |
| Classified | 2012-11-20 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2013-04-22 |
| Distributed | Nationwide (US) |
| Quantity | 282 units |
| Serial numbers | 00157087, 00157091, 00157288, 00157375, 00157405, RRCKOO011, RRHK00109, RRHKOO065, RRHKOO074, RRHKOO096, RRHKOO117 |
| Model numbers | 208030 |
Product
RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction
Reason for recall
The firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy System head pack. KCI has received complaints alleging patients experiencing skin breakdown on the head and face due to the positioning of the head pack. In a few instances, the patient received injuries ranging from Stage III to Stage IV pressure ulcers.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0409-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.