Recall Z-2742-2017— Pentax of America Inc
Class II · Terminated
Class II FDA medical device recall by Pentax of America Inc, initiated 2017-04-13, terminated 2019-03-22. FDA's recall record names no specific 510(k) clearance for this event. Product: 7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display, transfer, and store digital video data of behavior related to swallowing in the pharyngeal area for medical and pedagogical applications.. 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..
- Recalling firm
- Pentax of America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-04-13
- Terminated
- 2019-03-22
- Firm location
- Montvale, NJ, United States
Product description
7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display, transfer, and store digital video data of behavior related to swallowing in the pharyngeal area 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.