FDA Device recall Z-0413-2017
The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemaker…
- FDA Device
- Class II
- terminated
- Published 2016-11-23
On 2016-11-23 the FDA classified a Class II recall of The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemaker… by Sorin Group Usa, citing sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS Programmer because the residual longevity estimate may be less accurate.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0413-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-29 |
| Published | 2016-11-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Sorin Group Usa |
| Distribution | US |
Product
The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring implant patients.
Reason
Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS Programmer because the residual longevity estimate may be less accurate.
Identifiers
| code_info | Serial Numbers: NB1006418K NB1107409K NB1203456K NB1107407K NB1105419K NB0908405K NB1202447K NA0804365K NB1201447K NA08…Serial Numbers: NB1006418K NB1107409K NB1203456K NB1107407K NB1105419K NB0908405K NB1202447K NA0804365K NB1201447K NA0807425K NB0909407K NB1112470K NB0909402K NB1112474K NB1112444K NB1201403K NB1201402K NB1102423K NB1112471K NA0804393K NB1203431K NA0804389K NB1004403K NB1202418K NB1108403K NB1007410K NB1105438K NA0804367K NB1102406K NA0804384K NB1202458K NA0804321K NB1006415K NB1201455K NB1102402K NB1107417K NB1109421K NB1202454K NC1503413K NA0804353K NB1112482K NB1108404K NB1105436K NB0907430K NB1112485K NA0804343K NB1109418K NB1104409K NB1112414K NB0908415K NB1112407K NB1108425K NB1006402K NB1203428K NA0804426K NA0804390K NB0911402K NB0907419K NB0909417K NB1203415K NB1201442K NA0804363K NB0911414K NB0908411K NB0910412K NA0807414K NA0804387K NB1102405K NB1201409K NB1201423K NB1004416K NB1108401K NB1002406K NB1203429K NB0907433K NB1202474K NB1103415K NB1112427K NB1202462K NB1202469K NA0804319K NB1102425K NA0804339K NB1003402K NB1102404K NB0909410K NB0911404K NB1108429K NB1203444K NB120 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0413-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.