9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to… — Class II medical device recall Z-2745-2017
Terminated recall by Pentax of America Inc, reported 2017-07-26, distributed nationwide. Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C
| Recall number | Z-2745-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pentax of America Inc, Montvale, NJ, United States |
| Recall initiated | 2017-04-13 |
| Classified | 2017-07-18 |
| Reported by FDA | 2017-07-26 |
| Terminated | 2019-03-22 |
| Distributed | Nationwide (US) |
| Quantity | 241 units |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2745-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.