KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals: PDD Telescopes, Tricam SL II, and PDD Cam

FDA device recall Z-1216-2013 · posted 2013-05-08 · Terminated

Recall details

Recalling firm

Karl Storz Endoscopy America Inc

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.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

OAY

Quantity affected

15 units

Distribution

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

Date initiated

2012-08-16

Date posted

2013-05-08

Date terminated

2013-05-08

Location

El Segundo, CA