Home / Recalls / Karl Storz Endoscopy America Inc / Z-1216-2013

Z-1216-2013 Class II Terminated

Recalled by Karl Storz Endoscopy America Inc — El Segundo, CA

Recall Details

Product Type
Devices
Report Date
May 15, 2013
Initiation Date
August 16, 2012
Termination Date
May 8, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product 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.

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 by Karl Storz Endoscopy America Inc

  • Z-0527-2014 Class II — Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. (November 13, 2013)
  • Z-0526-2014 Class II — Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD2, (November 13, 2013)
  • Z-0465-2014 Class II — Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons (November 6, 2013)
  • Z-1728-2013 Class II — 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH (May 31, 2013)
  • Z-1311-2013 Class II — Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessories ( (June 1, 2009)
  • Z-1313-2013 Class II — Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, cutt (June 1, 2009)
  • Z-1306-2013 Class II — Electrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. electr (June 1, 2009)
  • Z-1312-2013 Class II — Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. electrod (June 1, 2009)
  • Z-1314-2013 Class II — Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode, cu (June 1, 2009)
  • Z-1307-2013 Class II — Electrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. elec (June 1, 2009)