FDA Device recall Z-0412-2017
The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and…
- FDA Device
- Class II
- terminated
- Published 2016-11-23
On 2016-11-23 the FDA classified a Class II recall of The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and… 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-0412-2017 |
| 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 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: BB0011103G BC0206105G BC0408064G BB0011111G BD0505094I BC0405016G BB0102071G BC0206096G BD0507033I BD05…Serial Numbers: BB0011103G BC0206105G BC0408064G BB0011111G BD0505094I BC0405016G BB0102071G BC0206096G BD0507033I BD0505110I BD0507019I BC0206076G BE0611036I BB0203034G BB0011099G BB0103048G BC0408067G BD0509044I BB0012010G BD0501100G BC0206131G BD0501096G BA0006167G BB0011169G BD0510018I BD0505029I BD0505039I BB0102074G BD0507014I BB0101021G BD0506112I BA0007003G BB0010078G BB0010213G BC0206089G BC0205079G BD0501099G BA0004162G BB0011101G BD0501094G BB0103027G BB0012068G BD0507005I BB0011003G BB0011086G BC0408057G BB0012075G BA0005050G BC0303071G BD0507060I BB0010268G BB0012154G BC0303073G BA0006171G BB0011080G BC0312045G BC0206144G BD0505016I BC0206029G BB0012184G BD0505018I BC0405050G BD0501085G BD0506136I BB0011083G BB0012056G BE0611013I BD0507053I BD0505028I BC0408078G BE0603002I BE0603012I BB0011166G BB0012150G BB0012067G BB0012171G BB0011020G BC0212074G BB0010250G BD0507025I BB0203012G BD0501061G BC0206110G BE0611023I BB0011141G BD0502041G BE0611087I BB0012017G BB0010193G BC020 |
|---|
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-0412-2017%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.