Recall Z-2743-2017 ยท GCW Transformer, Endoscope
Pentax of America Inc
9310HD Digital Video Capture Modules 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.
| Date | Apr 13, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | Pentax notified their customers on 4/13/2017 via USPS. |
| Quantity | 241 units in total |
| Distribution | Worldwide Distribution - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.