FDA Device recall Z-1217-2015
Rotoprone Therapy System
- FDA Device
- Class II
- terminated
- Published 2015-03-11
On 2015-03-11 the FDA classified a Class II recall of Rotoprone Therapy System by Arjo Hospital Equipment Ab, citing the recalled devices labeling and instructions for use contain unapproved medical claims.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1217-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-03 |
| Published | 2015-03-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Arjo Hospital Equipment Ab |
| Distribution | US |
Product
Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.
Reason
The recalled devices labeling and instructions for use contain unapproved medical claims.
Identifiers
| code_info | SERIAL NUMBERS: RRFK00041, RRFK00083, RRFK00232, RRFK00233, RRFK00276, RRFK00229, RRFK00215, RRFK00221, RRFK0…SERIAL NUMBERS: RRFK00041, RRFK00083, RRFK00232, RRFK00233, RRFK00276, RRFK00229, RRFK00215, RRFK00221, RRFK00243, RRFK00121, RRFK00263, RRFK00094, RRFK00150, RRFK00274, RRFK00103, RRFK00198, RRFK00256, RRFK00111, RRFK00290, RRFK00091, RRFK00044, RRFK00087, RRFK00241, RRFK00047, RRFK00186, RRFK00059, RRFK00170, RRFK00246, RRFK00064, RRFK00071, RRFK00289, RRFK00056, RRFK00078, RRFK00178, RRFK00051, RRFK00248, RRFK00155, RRFK00202, RRFK00247, RRFK00128, RRFK00228, RRFK00269, RRFK00126, RRFK00277, RRFK00207, RRFK00253, RRFK00067, RRFK00280, RRFK00108, RRFK00174, RRFK00161, RRFK00105, RRFK00125, RRFK00240, RRFK00052, RRFK00102, RRFK00147, RRFK00153, RRFK00082, RRFK00062, RRFK00225, RRFK00265, RRFK00070, RRFK00104, RRFK00123, RRFK00172, RRFK00085, RRFK00069, RRFK00190, RRFK00252, RRFK00287, RRFK00050, RRFK00119, RRFK00210, RRFK00239, RRFK00169, RRFK00191, RRFK00149, RRFK00168, RRFK00162, RRFK00226, RRFK00068, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1217-2015%22
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