Reported Jul 26, 2017 · Terminated

7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to…

Pentax of America Inc

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Pentax of America Inc · 3 Paragon Dr · Montvale, NJ · 07645-1782

Is this the product you have?

    • 7245C
    • 7245C/E
    • 7245D Computer
  • Digital Video System Product UsageThe 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
Lot codes and dates
    • 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
Amount recalled
241 units in total

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 22, 2019 · Data as of Sep 19, 4:53 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.