Device product
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.
Z-2744-2017
Product summary
- Event
- Event 77137
- Status
- Terminated
- Classification
- Class II
- Quantity
- 241 units in total
- Official record key
device-enforcement:Z-2744-2017
Official wording
Reason: 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.
Code information: 35865-10 35866-22 37879-10 38332-20 38935-159 40356-06 41305-16 41687-20 80002-01 80002-17 80279-12
Distribution pattern: Worldwide Distribution - US Nationwide
Derived failure modes
-
Unknown
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.