Z-2214-2023 Class II Ongoing
FDA device recall Z-2214-2023 was initiated by Digisonics, Inc on June 26, 2023 and is designated Class II. Reason for recall: Software issue The recall status is ongoing. Affected quantity: 32 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 26, 2023
- Initiation Date
- June 26, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32 units
Product Description
Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
Reason for Recall
Software issue
Distribution Pattern
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
Code Information
UDI?DI 00857050006014, Versions 4.8.2 SP6 - 4.8.3