FDA Medical Device Recalls (openFDA)
Digisonics, Inc: Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
- Recall number
- Z-2214-2023
- Recalling firm
- Digisonics, Inc
- Product
- Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
- Status
- Open, Classified
- Initiated
- 2023-06-26
- Posted
- 2023-07-20
- Terminated
- not on file
- Reason
- Software issue
- Root cause
- Labeling design
- Action
- Intelerad/Digisonics issued an "Urgent Medical Device Recall" notice to its consignees by email on 06/26/2023. The notice explained the issue, the hazard, and provided the following information: 1. Digisonics advises all users to pay close attention to the FW% calculation and ensure that it is correct per the actual measurements, which are also displayed within the report. 2. Digisonics will install a warning so that the user is aware that there may be a discrepancy in the FW% displayed. The message will inform of a discordant result, inform the user of what was previously selected and what it is being changed to, and allow the user to proceed with the changes or revert back. Action Required from Client 1. Advise all users of the Digisonics OBView software of this issue. 2. When the patch update becomes available work with your CSM to have it installed. If you have any questions, call 713-529-7979.
- Quantity
- 32 units
- 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
- Lot, serial or model codes
- UDI?DI 00857050006014, Versions 4.8.2 SP6 - 4.8.3
- 510(k) numbers
- ["K970402"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 1626313
- Firm city
- Raleigh
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28