TeraRecon Recalls Aquarius iNtuition Client Viewer Software Due to Anomaly
TeraRecon is recalling 91 units of the Aquarius iNtuition Client Viewer due to a software anomaly in the RECIST 1.1 evaluation criteria.
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, but the source text does not report any hospitalizations or injuries, and the hazard is a software anomaly rather than a direct physical injury risk, fitting the Moderate criteria for low-risk issues or voluntary precautionary recalls.
Plain-English summary
TeraRecon, Inc. is recalling 91 units of the Aquarius iNtuition Client Viewer, specifically the Findings Workflow module. The recall is due to a software anomaly related to the RECIST 1.1 target lesion evaluation criteria within the module.
The affected software versions are 4.4.11.82.6784, 4.4.11.116.7134, and 4.4.11.144.7589. The device is a Picture Archiving and Communications System intended for medical image analysis and viewing. The recall covers units distributed in the United States, Canada, Switzerland, Germany, France, and Italy.
The source text does not specify the corrective action or the specific steps users should take to resolve the anomaly. No illnesses or injuries are reported in the source text.
The recalled product
- Product
- Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture Archiving and Communications System; Findings Workflow Modules 4.4.11.82.6784, 4.4.11.116.7134, 4.4.11.144.7589. A fully-configured iNtuition system is capable of various image processing and…
- Manufacturer
- TeraRecon, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 91
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: AQ-UH6467
- AQ-UH7694
- AQ-UH8703
- AQ-UN5993
- AQ-UH8380
- AQ-UH8481
- AQ-UH8510
- AQ-UH8511
- AQ-UN5272
- AQ-UH7183
- AQ-UH5375
- AQ-UN5266
- AQ-UH6807
- AQ-UH6915
- AQ-UH8676
- AQ-UN5143
- AQ-UH8516
- AQ-UN5234
- AQ-UH7704
- AQ-UH7705
Distribution
Distributed nationwide across the United States.
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