Zvu® ZVU-3Recalls & reported problems
Diversatek Healthcare, Inc. · ZVU® Functional GI Software · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K012232); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Jul 25, 2023Open, Classified
GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
Z-2521-2023 · Root cause: Labeling Change Control · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K012232. One submission often covers many models, so check the product and lot details in each record.
- Z-1487-2012 · Feb 23, 2009 · TerminatedInsight rev H software. The InSIGHT Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons, and medically trained personnel for esophageal, biliary
Other System, Gastrointestinal Motility (Electrical) devices
- ManoScan 3890Given Imaging, Inc. · SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)90 reports
- Solar GI LGI H20, Trolley system G3-6Medical Measurement Systems B.V. · SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)1 recall3 reports
- Solar GI HRM H20, 24p, Trolley system G3-8Medical Measurement Systems B.V. · SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)1 recall2 reports
- Solar GI HRM H2O, 36p, Trolley system G3-12Medical Measurement Systems B.V. · SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)1 recall1 report
- EndoFLIP EF-100Covidien LP · System, Gastrointestinal Motility (Electrical)1 recall0 reports
- Solar GI HRM H20, 24p, Compact Pole system G3-7Medical Measurement Systems B.V. · SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)1 recall0 reports
- Endoflip RFG-EF100Covidien LP · SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)1 recall0 reports
- Zvu® HRAM-PROC-10Diversatek Healthcare, Inc. · System, Gastrointestinal Motility (Electrical)1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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