# FDA recall Z-2744-2017

> **Pentax of America Inc** · Class II · device recall initiated 2017-04-13.

## Product

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.

## 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.

## Distribution

Worldwide Distribution - US Nationwide

## Key facts

- **Recall number:** Z-2744-2017
- **Recalling firm:** Pentax of America Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-04-13
- **Report date:** 2017-07-26
- **Termination date:** 2019-03-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Montvale, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2744-2017

## Citation

> AI Analytics. FDA recall Z-2744-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2744-2017. Source: US FDA. Licensed CC0.

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