Rotoprone Therapy System — Class II medical device recall Z-1217-2015
Terminated recall by Arjo Hospital Equipment AB, reported 2015-03-11, distributed nationwide. The recalled devices labeling and instructions for use contain unapproved medical claims.
| Recall number | Z-1217-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arjo Hospital Equipment AB, Malm¿, N/A, Sweden |
| Recall initiated | 2014-12-03 |
| Classified | 2015-02-27 |
| Reported by FDA | 2015-03-11 |
| Terminated | 2015-10-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CA, CH, CN, DE, FR, IN, IT, JP, KW, MX, QA, SA |
| Quantity | 226 units |
| Reason classes | labeling, unapproved product |
| Serial numbers | RRFK00036, RRFK00037, RRFK00038, RRFK00039, RRFK00040, RRFK00041, RRFK00042, RRFK00043, RRFK00044, RRFK00045, RRFK00046, RRFK00047, RRFK00049, RRFK00050, RRFK00051, RRFK00052, RRFK00053, RRFK00054, RRFK00055, RRFK00056, RRFK00057, RRFK00059, RRFK00060, RRFK00061, RRFK00062 and 201 more |
Product
Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.
Reason for recall
The recalled devices labeling and instructions for use contain unapproved medical claims.
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-1217-2015. 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.