Verathon Recalls BladderScan and AortaScan Devices for Manual Clarification
Verathon is updating manuals for BladderScan and AortaScan devices to clarify they are not for diagnosing abdominal aortic aneurysms.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a documentation update to clarify intended use, which fits the rubric for moderate severity issues like labeling or documentation corrections.
Plain-English summary
Verathon, Inc. is recalling 2,524 units of BladderScan BVI 9600 and AortaScan AMI 9700 devices. The recall involves specific model numbers and serial numbers distributed in the United States and internationally.
The firm is providing customers with an updated Operations and Maintenance Manual for each of the affected devices. The updated manuals clarify that these devices should not be used for the screening, detection, or diagnosis of abdominal aortic aneurysms (AAAs).
Customers should check their device serial numbers against the list provided by the manufacturer and update their manuals accordingly.
The recalled product
- 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.
- Manufacturer
- Verathon, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE USA **************** A7001001
- A7001002
- A7001005
- A7001007
- A7001011
- A7001022
- A7001024
- A7001031
- A7001034
- A7001036
- A7001040
- A7001041
- A7001042
- A7001043
- A7001044
- A7001045
- A7001046
- A7001047
- A7001049
- A7001050
Distribution
Distributed nationwide across the United States.
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