Recall Z-1216-2013— Karl Storz Endoscopy America Inc
Class II · Terminated
Class II FDA medical device recall by Karl Storz Endoscopy America Inc, initiated 2012-08-16, terminated 2013-05-08. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Karl Storz Endoscopy America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-16
- Terminated
- 2013-05-08
- Firm location
- El Segundo, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.