PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: July 26, 2017 Initiated: April 13, 2017 #Z-2742-2017

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.

Details

Recalling Firm
Pentax of America Inc
Units Affected
241 units in total
Distribution
Worldwide Distribution - US Nationwide
Location
Montvale, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Pentax of America Inc. Units affected: 241 units in total.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 26, 2017. Severity: Moderate. Recall number: Z-2742-2017.