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

Recall Z-0232-2016 — Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.

U.S. FDA — Device Enforcement · United States · 2015-09-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0232-2016
Date of alert
2015-09-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Boston Scientific Corporation
Product category
device
Product type
Devices
Reported risk: Devices shipped to US in dual-channel rather than US approved single-channel RF Telemetry communication mode. While this does not impact therapy delivery of device; this can impact likelihood of successfully establishing telemetry during first scan of device when using a single-channel programmer. Telemetry can be established with additional scans; once established no further difficulty is expecte
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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