- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose calculation is updated correctly; however, any vials that were previously added to the cart are not automatically updated to reflect the revised calculation.
- Affected products (lot / model / serial)
- UDI/DI 00191506068264, All released software versions (V1.1.2, V1.2.1, V1.2.2. V2.0.1, V2.0.2)
- Units affected
- 68 units
- Distribution pattern
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IL, IN, LA, MA, MN, NE, NY, OH, OK, OR, SC, SD, TN, TX, UT, WA, WI, WV, WY.
- Firm location
- Maple Grove, MN, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Telephone
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2771-2026
- Recall initiated
- June 19, 2026
- FDA classification date
- July 22, 2026
- FDA report date
- July 29, 2026
- FDA event ID
- 99236
- Last updated on HTM Vibe
- August 4, 2026