The ORCHESTRA PLUS Programmer A portable device — Class II medical device recall Z-0413-2017
Terminated recall by Sorin Group USA, Inc., reported 2016-11-23, distributed nationwide. Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS Progr
| Recall number | Z-0413-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sorin Group USA, Inc., Arvada, CO, United States |
| Recall initiated | 2016-09-29 |
| Classified | 2016-11-15 |
| Reported by FDA | 2016-11-23 |
| Terminated | 2020-05-15 |
| Distributed | Nationwide (US) |
| Quantity | 586 programmers |
| Serial numbers | NA0705031K, NA0804305K, NA0804306K, NA0804308K, NA0804309K, NA0804310K, NA0804311K, NA0804312K, NA0804313K, NA0804315K, NA0804317K, NA0804318K, NA0804319K, NA0804320K, NA0804321K, NA0804323K, NA0804324K, NA0804329K, NA0804330K, NA0804333K, NA0804334K, NA0804336K, NA0804339K, NA0804340K, NA0804341K and 475 more |
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 for recall
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.
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-0413-2017. 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.