Fetal monitor F2Recalls & reported problems
Edan Instruments, Inc. · Class 2
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.
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
- Oct 24, 2025Open, Classified
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Z-1140-2026 · Root cause: Device Design · FDA record ↗
Other Transducer, Ultrasonic, Obstetric devices
- Fetal Monitor F3Edan Instruments, Inc. · Transducer, Ultrasonic, Obstetric1 recall0 reports
- Avalon US TransducerPhilips Medizin Systeme Böblingen GmbH · TRANSDUCER, ULTRASONIC, OBSTETRIC2 deaths29 reports
- Avalon CL Ultrasound Transducer Avalon Cableless US TransducerPhilips Medizin Systeme Böblingen GmbH · TRANSDUCER, ULTRASONIC, OBSTETRIC1 death3 reports
- Avalon Ultrasound Transducer USA Avalon US Transducer USAPhilips Medizin Systeme Böblingen GmbH · TRANSDUCER, ULTRASONIC, OBSTETRIC3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.