Reported Jul 26, 2017 · Terminated
9200C and 9200D Laryngeal Strobe 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?
- 9200C and 9200D
- 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
141 of 141 codes
4055222679-0523546-0623546-0724036-0624045-0324045-0624045-0824045-0924049-0124049-0324049-0824231-1024556-0124556-0624965-0725282-0325351-0625459-0125459-0725459-0825459-0925461-0125461-0325461-0525461-0725461-0925466-0725466-0825964-0125964-0325964-1125965-0225965-0525965-1226035-1326055-0226055-1326055-1826056-0426056-0526056-0826057-0326057-1826058-1826058-2026870-0926871-0226871-0226871-0326871-0326871-0726871-1126871-1226871-1426871-1726871-1826872-0526872-0626872-08
- 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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