FDAFDA · Food and drugs·Recall number Z-2744-2017
9400 Laryngeal Strobe Product Usage: The 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.
Published July 26, 2017 · Recall initiated: April 13, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Pentax of America Inc
- Distributor
- Worldwide Distribution - US Nationwide
- Lot
- 35865-10 35866-22 37879-10 38332-20 38935-159 40356-06 41305-16 41687-20 80002-01 80002-17 80279-12
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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