KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals: PDD Telescopes, Tricam SL II, and PDD Camera Heads. Used as an optional accessory to white light cystoscopy when used in combination with the diagnostic imaging drug Cysview.
Class I - DangerousWhat Should You Do?
- Check if you have this product: The device Instruction Manual recall, which includes: 1) Telescope, 2) Camera Head, and 3) Camera System. Serial Numbers: ZZ2008 ZZ2016 ZZ2012 ZZ2019 TY2024 ZZ2013 TY2026 TY2025 TY2028 TY2021 ZZ2007 ZZ2020 TX2036 TX2033 ZZ2017, and TX2035.
- 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:
- Karl Storz Endoscopy America Inc
- Reason for Recall:
- The recall was initiated because Karl Storz has confirmed that the Photodynamic Diagnosis (PDD) D-Light C System instruction manuals have important safety-related changes.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals: PDD Telescopes, Tricam SL II, and PDD Camera Heads. Used as an optional accessory to white light cystoscopy when used in combination with the diagnostic imaging drug Cysview.
Product Codes/Lot Numbers:
The device Instruction Manual recall, which includes: 1) Telescope, 2) Camera Head, and 3) Camera System. Serial Numbers: ZZ2008 ZZ2016 ZZ2012 ZZ2019 TY2024 ZZ2013 TY2026 TY2025 TY2028 TY2021 ZZ2007 ZZ2020 TX2036 TX2033 ZZ2017, and TX2035.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1216-2013
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