Recall – Speech pathology system software error may result in mismatched patient files

Company: Pentax of America Inc
Date of Enforcement Report: 11/4/2020
Class II

PRODUCT

9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),

Recall Number: Z-0292-2021

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/MANUFACTURER

Pentax of America Inc. on 9/22/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

39 total

DISTRIBUTION

U.S. Nationwide and Canada

Upcoming Training

Agile Methods for Medical Device and Health IT Software

One day course that expands on the software risk management topics covered in our IEC 62304 and other Emerging Standards for Medical Device and HealthIT Software course. Essentially the same topics are covered but in greater depth with more attention to hands-on analysis of examples.

Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.