FDA Device recall Z-1216-2015
RotoRest Delta Advanced Therapy System
- FDA Device
- Class II
- terminated
- Published 2015-03-11
On 2015-03-11 the FDA classified a Class II recall of RotoRest Delta Advanced 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-1216-2015 |
| 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
RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.
Reason
The recalled devices labeling and instructions for use contain unapproved medical claims.
Identifiers
| code_info | SERIAL NUMBERS: RRHK00122, 00157053, RRHK00063, RRHK00123, 00157182, 00157217, 00157058, RRHK00060, 00157184…SERIAL NUMBERS: RRHK00122, 00157053, RRHK00063, RRHK00123, 00157182, 00157217, 00157058, RRHK00060, 00157184, 00157346, RRHK00110, RRHK00119, 00157373, 00157027, 00157074, 00157220, 00157423, 00157088, 00157302, 00157365, RRHK00112, RRHK00001, RRHK00116, RRHK00003, 00157200, RRHK00014, 157030, 00157461, 00157464, 00157089, 00157304, 00157299, RRHK00121, 00157264, RRHK00071, RRHK00007, 00157243, 00157086, 00157432, RRHK00067, RRHK00097, 00157159, 00157258, 00157362, RRHK00118, RRHK00099, 00157230, RRHK00036, 00157471, 00157013, RRHK00015, 00157203, RRHK00005, 00157014, 00157358, 00157007, 00157344, 00157161, 00157426, RRHK00037, 00157295, 00157054, 00157308, 00157189, RRHK00069, 00157126, RRHK00098, 00157097, RRHK00006, RRHK00120, RRHK00102, RRHK00004, RRHK00101, 00157348, RRHK00107, 00157196, RRHK00066, RRHK00044, 00157303, RRHK00002, 00157305, 00157240, 00157194, 00157244, RRHK00016, 00157321, RRH |
|---|
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-1216-2015%22
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