BladderScan BVI 9600 — Class II medical device recall Z-1091-2016
Terminated recall by Verathon, Inc., reported 2016-03-16, distributed nationwide. The firm is providing customers with an updated Operations and Maintenance Manual for each of the BladderScan
| Recall number | Z-1091-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Verathon, Inc., Bothell, WA, United States |
| Recall initiated | 2015-11-30 |
| Classified | 2016-03-10 |
| Reported by FDA | 2016-03-16 |
| Terminated | 2016-10-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, CN, CZ, DE, FR, GB, LU, NL, NO, SA, SE, TW |
| Model numbers | 0270-0451, 0270-0452, 0270-0636, 0270-0639, 0270-0754, U270-0451, U270-0636 |
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.
Reason for recall
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1091-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.