Reported Jul 26, 2017 · Terminated
9310HD Digital Video Capture Modules Product Usage: The 9310HD is used to electronically record, display, transfer, and…
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?
- 9310HD Digital
- Video Capture Modules Product UsageThe 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications
- Lot codes and dates
8084738953-0940156-0140156-0940158-1540669-0240669-0940670-0542094-0545852-0646800-0547452-0148653-0248653-0349242-0272872-49A80361-1480362-0180362-0280365-0580399-0580399-0980481-0780841-0280842-0580847-0680878-0780879-0680879-0880880-0180881-0580883-0380884-0380886-0680886-1180886-1380887-0280887-08
- 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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