Reported May 15, 2013 · Terminated
KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals: PDD Telescopes, Tricam SL II, and PDD…
Karl Storz Endoscopy America Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Karl Storz Endoscopy America Inc · 2151 East Grand Avenue · El Segundo, CA · 90245
Is this the product you have?
- KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System
- Instruction ManualsPDD 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
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 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. - Amount recalled
- 15 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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