Class II — Verathon, Inc.
| Recalling firm | Verathon Inc. |
|---|---|
| Registered facility | Verathon Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The firm is providing customers with an updated Operations and Maintenance Manual for each of the BladderScan BVI 9600 and AortaScan AMI 9700 devices. The updated Operations and Maintenance Manuals clarify that these devices should not be used for the screening, detection, or diagnosis of abdominal aortic aneurysms (AAAs). |
| Product | BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan AMI 9700, Model Numbers: 0270-0636, 0270-0639, and U270-0636. |
| Quantity | 2524 units total (1441 units of BVI 9600 and 820 units of AMI 9700 in US; 209 units of BVI 9600 and 54 units of AMI 9700 OUTSIDE the US |
| Distribution | Worldwide Distribution - US (nationwide) and to the countries of : Guam, United Arab Emirates, Australia, Belgium, Canada , China, Czech Republic, France, Germany, Luxembourg, Netherlands, Norway, Saudi Arabia, Sweden , Taiwan, and United Kingdom |
| Initiated | 2015-11-30 |
| Classified | 2016-03-10 |
| Terminated | 2016-10-12 |
| Recall number | Z-1091-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Verathon, Inc. (Z-1091-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72486/
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