9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
Reported: November 4, 2020 Initiated: September 22, 2020 #Z-0292-2021
Product Description
9372HD Digital Capture (ver. 1.1.0 + w/ 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.
Details
- Recalling Firm
- Pentax of America Inc
- Units Affected
- 39 total
- Distribution
- US Nationwide and Canada
- Location
- Montvale, NJ
Frequently Asked Questions
What product was recalled? ▼
9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),. Recalled by Pentax of America Inc. Units affected: 39 total.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 4, 2020. Severity: Moderate. Recall number: Z-0292-2021.
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