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.
This recall has been terminated (originally issued April 13, 2017).
- Company
- Pentax Of America Inc
- Recall Initiated
- April 13, 2017
- Terminated
- March 22, 2019
- Recall Number
- Z-2742-2017
- Quantity
- 241 units in total
- Firm Location
- Montvale, NJ
- Official Source
- View on FDA website ↗
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
Worldwide Distribution - US Nationwide
Lot / Code Info
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
Root Cause
Device Design
Action Taken
Pentax notified their customers on 4/13/2017 via USPS.