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U.S. Department of Health and Human Services

Class 2 Device Recall Karl Storz Photodynamic Diagnosis (PDD) DLight C System,

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  Class 2 Device Recall Karl Storz Photodynamic Diagnosis (PDD) DLight C System, see related information
Date Initiated by Firm August 16, 2012
Date Posted May 08, 2013
Recall Status1 Terminated 3 on May 08, 2013
Recall Number Z-1216-2013
Recall Event ID 60555
Product Classification Light source system, diagnostic endoscopic - Product Code OAY
Product 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.
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.
Recalling Firm/
Manufacturer		 Karl Storz Endoscopy America Inc
2151 East Grand Avenue
El Segundo CA 90245
For Additional Information Contact
818-218-8100
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action A Safety Alert letter, dated 8/16/12, was sent to all their customers to inform them that there is a labeling error in which important safety-related changes were made to the KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System instruction manuals. The correct Ethylene Oxide (EtO) Sterilization set point for Relative Humidity should read, =70% RH. The correction applies to the PDD Camera Head instruction manual, PDD Rigid Telescopes instruction manual, and Tricam SL II instruction manual, the three component manuals indicated for use within the KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System. The letter instructed the customers to place each of the three enclosed stickers, in the appropriate instruction manual. Customers are instructed to cover the erroneous information with the provided stickers as indicated. Customers with any questions regarding the proper use of the device, are instructed to contact Karl Storz's Technical Support Department at 800-421-0837, Ext. 5350, during office hours; or Ext. 7222, 24 hours/7 days a week for emergencies.
Quantity in Commerce 15 units
Distribution Nationwide distribution: USA including states of: IL, CA, WV, TX, SC, WI, NY, PA, NE, NJ, MD, OH, IA, and NC.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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