Z-2744-2017 Class II Terminated
FDA device recall Z-2744-2017 was initiated by Pentax of America Inc on April 13, 2017 and is designated Class II. 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. The recall status is terminated (terminated March 22, 2019). Affected quantity: 241 units in total.
Recall Details
- Product Type
- Devices
- Report Date
- July 26, 2017
- Initiation Date
- April 13, 2017
- Termination Date
- March 22, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 241 units in total
Product Description
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.
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.
Distribution Pattern
Worldwide Distribution - US Nationwide
Code Information
35865-10 35866-22 37879-10 38332-20 38935-159 40356-06 41305-16 41687-20 80002-01 80002-17 80279-12