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Terminated

9310HD Digital Video Capture Modules 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.

FDA Recall Z-2743-2017 · Posted None

Recalling FirmPentax of America Inc
Recall StatusTerminated
Product CodeGCW
Date Initiated2017-04-13
Date Terminated2019-03-22
Product Quantity241 units in total

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.

Firm Action

Pentax notified their customers on 4/13/2017 via USPS.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - US Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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