Pentax of America Inc recalls 9400 Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital…

Recall date

April 13, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2744-2017

FDA classification

Class II

Brand / firm

Pentax of America Inc

Sold / distributed

Worldwide Distribution - US 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.