KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals: PDD Telescopes, ...

FDA Device Recall #Z-1216-2013 — Class II — August 16, 2012

Recall Summary

Recall Number Z-1216-2013
Classification Class II — Moderate risk
Date Initiated August 16, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Karl Storz Endoscopy America Inc
Location El Segundo, CA
Product Type Devices
Quantity 15 units

Product 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.

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.

Distribution Pattern

Nationwide distribution: USA including states of: IL, CA, WV, TX, SC, WI, NY, PA, NE, NJ, MD, OH, IA, and NC.

Lot / Code Information

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.

Other Recalls from Karl Storz Endoscopy America Inc

Recall # Classification Product Date
Z-0526-2014 Class II Intubation Flexible Fiberscope, Models: 11301AA... Nov 13, 2013
Z-0527-2014 Class II Broncho Flexible Fiberscope, models: 11001BN1, ... Nov 13, 2013
Z-0465-2014 Class II Axillent Debakey Grasping Forceps, Part No. 338... Nov 6, 2013
Z-1728-2013 Class II 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile... May 31, 2013
Z-1311-2013 Class II Electrode, Roller, Vaporization, 24FR (27050RK/... Jun 1, 2009

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.