Z-2214-2023Class II

Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software

Name: Z-2214-2023 Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
Creator: Digisonics, Inc
Published: 2023-06-26
License: https://open.fda.gov/license/

Digisonics, Inc / initiated 2023-06-26 / Open, Classified / root cause: labeling and UDI

FDA source

Digisonics, Inc began a recall of Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software on 2023-06-26. FDA classified it as Class II and gives the reason as "Software issue". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2214-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-26
Posted: 2023-07-20
Recalling firm: Digisonics, Inc
Product: Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Software issue
Root cause tag: labeling and UDI
FDA 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 in commerce: 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
Product codes and lots: UDI?DI 00857050006014, Versions 4.8.2 SP6 - 4.8.3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2214-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2214-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20

Product code LLZ

K970402Class IIDoctors Review SystemDigisonics, Inc. / cleared 1997-03-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)