Recall Z-0293-2021— Pentax of America Inc
Class II · Terminated
Class II FDA medical device recall by Pentax of America Inc, initiated 2020-09-22, terminated 2022-05-16. FDA's recall record names no specific 510(k) clearance for this event. Product: 9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal. 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..
- Recalling firm
- Pentax of America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-09-22
- Terminated
- 2022-05-16
- Firm location
- Montvale, NJ, United States
Product description
9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.