Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
FDA device recall Z-2214-2023 · posted 2023-07-20 · Open, Classified
Recall details
- Recalling firm
- Digisonics, Inc
- Reason for recall
- Software issue
- Action taken
- 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.
- Root cause
- Labeling design
- Status
- Open, Classified
- Product code
- LLZ
- Quantity affected
- 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
- Date initiated
- 2023-06-26
- Date posted
- 2023-07-20
- Location
- Raleigh, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DOCTORS REVIEW SYSTEM (K970402) | Digisonics, Inc. | 1997-03-26 |