Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers: 001343 000488 000903 001404 000923 001352 001441 000203 000224 000255 000284 000434 000441 000445 000501 000515 000519 000521 000534 000536 000546 000553 000578 000588 000601 000602 000605 000606 000609 000610 000616 000617 000620 000628 000631 000633 000634 000636 000637 000638 000643 000644 000661 000664 000666 000667 000669 000671 000673 000677 000679 000682 000688 000690 000691 000700 000710 000717 000719 000720 000723 000726 000746 000757 000765 000924 001125 001556 001562 001564 001571 001574 001615 000598
- 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:
- Boston Scientific Corporation
- Reason for Recall:
- There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.
Product Codes/Lot Numbers:
Serial Numbers: 001343 000488 000903 001404 000923 001352 001441 000203 000224 000255 000284 000434 000441 000445 000501 000515 000519 000521 000534 000536 000546 000553 000578 000588 000601 000602 000605 000606 000609 000610 000616 000617 000620 000628 000631 000633 000634 000636 000637 000638 000643 000644 000661 000664 000666 000667 000669 000671 000673 000677 000679 000682 000688 000690 000691 000700 000710 000717 000719 000720 000723 000726 000746 000757 000765 000924 001125 001556 001562 001564 001571 001574 001615 000598
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-3260-2018
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