FDA-Device2017-07-26Class II
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.
Pentax of America Inc
Hazard
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.
Sold states
Worldwide Distribution - US Nationwide
Affected count
241 units in total
Manufactured in
3 Paragon Dr, N/A, Montvale, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2742-2017Don't want to check this manually?
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