FDA Medical Device Recalls (openFDA)
Spectral Instruments Inc: Lago X
- Recall number
- Z-2939-2026
- Recalling firm
- Spectral Instruments Inc
- Product
- Lago X
- Status
- Open, Classified
- Initiated
- 2026-07-24
- Posted
- 2026-08-14
- Terminated
- not on file
- Reason
- Momentary absence of On-Screen "X-Ray On" banner during run readiness check.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Customer notification letters dated August 21, 2023 and allows for scheduling of the software upgrade corrections.
- Quantity
- 40
- Distribution
- United States.
- Lot, serial or model codes
- All serial numbers.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RCE
- Firm FEI
- 3002679892
- Firm city
- Tucson
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28