Recall Z-0292-2021 ยท OUG Medical Device Data System
Pentax of America Inc
9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
| Date | Oct 23, 2020 (initiated Sep 22, 2020) |
| Status | Terminated |
| Reason | There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does not occur at the time the user performs and initially reviews an exam; it is not evident until a follow-up review occurs. |
| Root cause | Software design |
| Action | URGENT MEDICAL DEVICE CORRECTION notification letters were sent on 9/22/20. Customer Instructions: Enclosed with this letter is a Field Correction Response Form which identifies the serial numbers of the affected products your facility owns. PENTAX Medical will be taking a two step approach to contain and correct the problem. o First, we will contact you to schedule a time for our Field Service to temporarily disable file transfer to endoPortal. o During the time that file transfers to endoPortal are disabled, you can continue to create and save exam video files. When this issue is resolve |
| Quantity | 39 total |
| Distribution | US Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.