Recall Z-1216-2013 ยท OAY Light Source System, Diagnostic Endoscopic
Karl Storz Endoscopy America Inc
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.
| Date | May 8, 2013 (initiated Aug 16, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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-L |
| Quantity | 15 units |
| Distribution | Nationwide distribution: USA including states of: IL, CA, WV, TX, SC, WI, NY, PA, NE, NJ, MD, OH, IA, and NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.