Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0413-2017 — 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.

U.S. FDA — Device Enforcement · United States · 2016-09-29 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0413-2017
Date of alert: 2016-09-29
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Sorin Group USA, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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