Spectral Instruments Lago X Medical Device Recalled for Display Glitch
Spectral Instruments Inc is recalling 40 Lago X units because the 'X-Ray On' banner may briefly disappear during the run readiness check.
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, and the hazard involves a momentary display absence during a readiness check, which is a functional defect without reported injuries or hospitalizations, fitting the Moderate criteria for low-risk contamination or minor defects.
Plain-English summary
Spectral Instruments Inc is recalling 40 units of the Lago X medical device. The recall was initiated due to a software or display issue where the on-screen "X-Ray On" banner may momentarily disappear during the run readiness check.
The affected units are distributed in the United States. The recall covers all serial numbers for the 40 units involved. This issue could potentially affect the visual confirmation of the device's status during operation.
Consumers and healthcare providers should contact Spectral Instruments Inc for further instructions on how to resolve the issue or replace the affected units.
The recalled product
- Product
- Lago X
- Manufacturer
- Spectral Instruments Inc
- Hazard
- Affected units
- 40
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)
- All serial numbers.
Distribution
Distribution scope not specified by the agency.
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