Lago X X-ray instrument recall due to labeling discrepancies
Spectral Instruments Inc is recalling the Lago X X-ray instrument because its safety and manufacturing date labels do not match FDA requirements.
What this means for you
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 an FDA Class II medical device recall for a labeling discrepancy with no reported injuries or safety incidents. Labeling errors that do not involve missing critical safety information on high-risk devices are typically classified as moderate.
Plain-English summary
Spectral Instruments Inc is recalling the Lago X X-ray instrument. The X-ray safety and manufacturing date labels affixed to the device do not correspond exactly to the labeling stipulated by the FDA/CDRH.
Affected units include 39 Lago X instruments distributed in the US. The device in question is identified by accession number 2510787-000.
Consumers who have purchased this device should contact Spectral Instruments Inc for further guidance regarding the labeling discrepancy.
The recalled product
- Product
- Lago X
- Manufacturer
- Spectral Instruments Inc
- Category
- Medical Device — X-ray Equipment
- Hazard
- Affected units
- 39
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)
- Accession number 2510787-000
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Spectral Instruments Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Spectral Instruments Inc
See all →- ModerateSpectral Instruments Recalls 35 Ami HTX X-Ray Units
FDA (Devices) · 2026-08-26
- ModerateSpectral Instruments Lago X Medical Device Recalled for Display Glitch
FDA (Devices) · 2026-08-26
- ModerateAmi HTX X-ray Instrument Safety Labels Do Not Match FDA Requirements
FDA (Devices) · 2025-06-25
Same hazard · mis labeling
See all →- ModerateAllies Group Recalls Subpotent SPF 50 Sunscreen Gel Sachets
FDA (Drugs) · 2026-09-09
- HighPrince Bakery Recalls Italian and French Bread for Undeclared Sesame
FDA (Food) · 2026-09-09
- LowB Braun Recalls Discofix Stopcock Sets Due to Incorrect Expiration Date
FDA (Devices) · 2026-09-09
- ModerateWonton Skin Recalled for Undeclared Red Dye
FDA (Food) · 2026-09-09
- ModerateWonton Specialist Cooked Noodle Recalled for Undeclared Red Dye
FDA (Food) · 2026-09-09