CLASS II ONGOING Device recall · Reported 26 Jul 2023 · FDA Enforcement Report
OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting recalled
Digisonics is recalling OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting, distributed in 19 states. The recall was initiated on 26 Jun 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2214-2023
- FDA event ID
- 92619
- Recalling firm
- Digisonics, Raleigh, NC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Jun 2023
- FDA classified
- 20 Jul 2023
- Reported
- 26 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 26 Jun 2023 | Recall initiated by company | |
| 20 Jul 2023 | Classified by FDA | +24 days |
| 26 Jul 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Software issue
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
Where it was distributed
US Distribution: AK, NH, WY, TX, NE, CA, MD, TX, OR IA, IL, MO, OR, NY, UT, PA, MA, GA, VA, WA, WI, and Internationally to :Aruba
AlaskaCaliforniaGeorgiaIowaIllinoisMassachusettsMarylandMissouriNebraskaNew HampshireNew YorkOregonPennsylvaniaTexasUtahVirginiaWashingtonWisconsinWyoming
Questions about this recall
Why was it recalled?
Software issue
Which lots are affected?
UDI?DI 00857050006014, Versions 4.8.2 SP6 - 4.8.3
Where was it sold?
US Distribution: AK, NH, WY, TX, NE, CA, MD, TX, OR IA, IL, MO, OR, NY, UT, PA, MA, GA, VA, WA, WI, and Internationally to :Aruba
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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