Z-2742-2017 Class II Terminated

Recalled by Pentax of America Inc — Montvale, NJ

Recall Details

Product Type
Devices
Report Date
July 26, 2017
Initiation Date
April 13, 2017
Termination Date
March 22, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
241 units in total

Product Description

7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display, transfer, and store digital video data of behavior related to swallowing in the pharyngeal area for medical and pedagogical applications.

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.

Distribution Pattern

Worldwide Distribution - US Nationwide

Code Information

24966-06 25281-01 26060-10 26874-03 26874-06 28669-04 28671-02 28671-04 28675-04 30150-02 30150-03 30604-09 31525-03 31525-09 31526-19 32945-04 36453-10 36453-13 38476-04 38476-07 38748-101 38976-04 39444-02 39471-09 39508-151 41735-05 41735-08 41735-11 45810-14 47969-04 80397-09 80400-01 80850-02 25631-07 27406.05 28677-10 30737-12 34599-04 37836-05 4124-07 45735-03 45810-08 80910-02