Medical device recalls Moderate risk

Pentax of America Inc recalls 9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and sto…

Recall date
April 13, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2745-2017
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

9200C and 9200D 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.

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