Diversatek Healthcare is recalling 20 units of its ZVU Functional GI Software (REF: ZVU-3) because the software was incorrectly labeled as revision 3.3.0 when it is actually revision 3.2.0. This labeling error means the software version does not match the documentation provided to the user. The affected software was shipped between May 4, 2023, and July 6, 2023, and was distributed to several U.S. states and international locations including Japan and Saudi Arabia.
The incorrect labeling could lead to confusion regarding the software's actual features or capabilities, potentially resulting in improper use or interpretation of diagnostic data during gastrointestinal procedures. No injuries or specific incidents have been reported, and the risk level is considered low.
Manufacturer Notification and Correction
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Sources: FDA iRES · Raw API Response
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