Reported Nov 4, 2020 · Terminated
9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
Pentax of America Inc
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pentax of America Inc · 3 Paragon Dr · Montvale, NJ · 07645-1782
Is this the product you have?
- 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
- Lot codes and dates
- All systems with version 1.1.0 or higher
- Computer Serial Numbers
84086-0184533-0184090-1684090-1584090-1484090-1184090-0984090-1084090-0884088-1384088-1184528-0884087-0684087-0384538-0684088-1484089-0284089-0684089-0384529-0484528-0581536-0684091-0184089-1681536-1284532-1181538-0584090-0284089-1384089-1284090-0684087-0484531-1284531-1184531-1084531-1384091-1684533-1184533-12
- Amount recalled
- 39 total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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