Class 2 Device Recall Laryngeal Strobe

• Date Initiated by Firm: April 13, 2017
• Create Date: July 18, 2017
• Recall Status: Terminated on March 22, 2019
• Recall Number: Z-2744-2017
• Recall Event ID: 77137
• Product Classification: Transformer, endoscope - Product Code GCW
• Product: 9400 Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
• Code Information: 35865-10 35866-22 37879-10 38332-20 38935-159 40356-06 41305-16 41687-20 80002-01 80002-17 80279-12
• Recalling Firm/ Manufacturer: Pentax of America Inc; 3 Paragon Dr; Montvale NJ 07645-1782
• For Additional Information Contact: 800-431-5880
• Manufacturer Reason for Recall: Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
• FDA Determined Cause: Device Design
• Action: Pentax notified their customers on 4/13/2017 via USPS.
• Quantity in Commerce: 241 units in total
• Distribution: Worldwide Distribution - US Nationwide
• 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.