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

Recall Z-0965-2013 — Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

U.S. FDA — Device Enforcement · United States · 2013-03-01 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0965-2013
Date of alert: 2013-03-01
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Boston Scientific CRM Corp
Product category: device
Product type: Devices

Reported risk: An internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. Should this occur, the defibrillator would not be able to deliver therapy or communicate with the Q-TECH Model 2020 programmer, and would be unable to emit tones or otherwise respond to magnet application.

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

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Recall Z-0965-2013 — Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

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