Raleigh, NC, United States
Digisonics, Inc recalls
1 recall recorded since 2018, most recently on 26 June 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 26 June 2023
- Reason
- Software issue
- Distribution
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2214-2023
- Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.