Reported Jul 26, 2017 · Terminated
9400 Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital…
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?
- 9400
- Laryngeal Strobe 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
35865-1035866-2237879-1038332-2038935-15940356-0641305-1641687-2080002-0180002-1780279-12
- 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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