CLASS II Device recall · Reported 26 Jul 2017 · FDA Enforcement Report

7245C, 7245C/E, 7245D Computer Digital Video System recalled

Pentax of America is recalling 7245C, 7245C/E, 7245D Computer Digital Video System, distributed nationwide in the US. The recall was initiated on 13 Apr 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes24966-06 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

Quantity recalled241 units in total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2742-2017
FDA event ID: 77137
Recalling firm: Pentax of America, Montvale, NJ
Classification: Class II
Status: Terminated
Recall initiated: 13 Apr 2017
FDA classified: 18 Jul 2017
Reported: 26 Jul 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

13 Apr 2017	Recall initiated by company
18 Jul 2017	Classified by FDA	+96 days
26 Jul 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution - US Nationwide

Nationwide

Questions about this recall

Why was it 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.

Which lots are affected?

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

Where was it sold?

Worldwide Distribution - US Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 77137

This product is part of a recall event; the main page for the event is 9400 Laryngeal Strobe recalled by Pentax of America.

Reported	Class	Recall	Company	Reason	Where
26 Jul 2017	CLASS II	9400 Laryngeal Strobe recalled by Pentax of America	Pentax of America	Other	Nationwide
26 Jul 2017	CLASS II	9200C and 9200D Laryngeal Strobe recalled by Pentax of America	Pentax of America	Other	Nationwide
26 Jul 2017	CLASS II	9310HD Digital Video Capture Modules recalled by Pentax of America	Pentax of America	Other	Nationwide

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All 38

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