Z-0292-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 4, 2020
- Initiation Date
- September 22, 2020
- Termination Date
- May 16, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39 total
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.
Distribution Pattern
US Nationwide and Canada
Code Information
All systems with version 1.1.0 or higher; Computer Serial Numbers: 84086-01 84533-01 84090-16 84090-15 84090-14 84090-11 84090-09 84090-10 84090-08 84088-13 84088-11 84528-08 84087-06 84087-03 84538-06 84088-14 84089-02 84089-06 84089-03 84529-04 84528-05 81536-06 84091-01 84089-16 81536-12 84532-11 81538-05 84090-02 84089-13 84089-12 84090-06 84087-04 84531-12 84531-11 84531-10 84531-13 84091-16 84533-11 84533-12