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
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
Questions about this recall
Is 7245C, 7245C/E, 7245D Computer Digital Video System recalled?
Yes. Pentax of America recalled 7245C, 7245C/E, 7245D Computer Digital Video System on 13 Apr 2017. The recall is Class II and its status is Terminated. Recall number Z-2742-2017.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Pentax of America
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|---|---|---|---|---|---|
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