Product Wiki · Recalls · U.S. FDA — Device Enforcement

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. — recall Z-2745-2017

U.S. FDA — Device Enforcement · United States · 2017-04-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2745-2017
Date of alert
2017-04-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Pentax of America Inc
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.