Ansar ANX-3.0 Autonomic Monitor Blood Pressure Circuit Recall
Ansar Group is recalling 351 ANX-3.0 Autonomic Monitor systems because the blood pressure circuit may fail to inflate the cuff or activate, resulting in no blood pressure measurement.
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: The recall is classified as FDA Class II. The hazard is a functional failure resulting in a lack of measurement rather than a direct physical injury or acute health risk, fitting the criteria for a moderate severity recall involving a risk-of-harm product where injury has not been reported.
Plain-English summary
Ansar Group, Inc. d/b/a Ansar Medical Technologies, Inc. is recalling the blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The recall involves 351 units with unit numbers 193 through 1203. The ANX 3.0 system includes a Patient Physiological Monitor, Laptop Computer, Stand with wheels, Patient cables, and Software components. The device is also referred to as the ANS-C3000.
The recall is being conducted because the blood pressure circuit occasionally fails to inflate the blood pressure cuff and fails to activate, resulting in no blood pressure being measured. This failure means the device cannot perform its intended function of measuring blood pressure.
The affected units were distributed nationwide. Healthcare providers and users of the ANSAR ANX-3.0 Autonomic Monitor system should stop using the affected blood pressure circuits and contact Ansar Group for further instructions on repair or replacement.
The recalled product
- Product
- Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.0 system is comprised of these components. 1. Patient Physiological Monitor, 2. Laptop Computer, 3. Stand w/wheels, 4. Patient cables, 5. Software components (Respiratory and Cardiac…
- Hazard
- Affected units
- 351
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 (1)
- ANX 3.0 unit numbers: 193 through 1203.
Distribution
Distributed nationwide across the United States.
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