Merlin PCS programmer (Model # 3650), Software (Model # 3330)
Class I - DangerousWhat Should You Do?
- Check if you have this product: Software Versions: 24.1.1 rev1 (US), 23.1.2 rev 1 (OUS), 23.1.3 (Japan), and 23.1.4 rev 1 (Canada)
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- St Jude Medical Inc.
- Reason for Recall:
- The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Merlin PCS programmer (Model # 3650), Software (Model # 3330)
Product Codes/Lot Numbers:
Software Versions: 24.1.1 rev1 (US), 23.1.2 rev 1 (OUS), 23.1.3 (Japan), and 23.1.4 rev 1 (Canada)
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2329-2018
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