PINPOINT Endoscopic Fluorescence Imaging System
Class I - DangerousWhat Should You Do?
- Check if you have this product: Rev. J, Rev. K, Rev. L and Rev. M Model Number : PC9000
- 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:
- Novadaq Technologies Inc.
- Reason for Recall:
- It has been determined that the PINPOINT Operator's Manual does not contain validated parameters for gravity-cycle autoclave sterilization of the PINPOINT laparoscopes and light guide cable in the reprocessing tray.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
PINPOINT Endoscopic Fluorescence Imaging System
Product Codes/Lot Numbers:
Rev. J, Rev. K, Rev. L and Rev. M Model Number : PC9000
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1032-2016
Related Recalls
The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.