FDA Medical Device Recalls (openFDA)
Olympus Scientific Solutions Americas: Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10. Mobile X-ray System.
- Recall number
- Z-1991-2015
- Recalling firm
- Olympus Scientific Solutions Americas
- Product
- Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10. Mobile X-ray System.
- Status
- Open, Classified
- Initiated
- 2015-06-09
- Posted
- 2015-07-31
- Terminated
- not on file
- Reason
- Higher than published scatter around the probe head when testing some samples. At the point the customer would interact directly with the instrument (Trigger position), most readings were lower. However, measurements around the probe head were higher particularly on samples know to be highly scattering (plastics, soils) with minimal increases on high density samples (steel, aluminum).
- Root cause
- Component change control
- Action
- Olympus Scientific Solutions planned action: 1. Notify product managers as to potential issues 2. Distribute new table and notice to instrument owners 30 JUL 15 3. Post new table on website for access 15 JUN 15
- Quantity
- 1047
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RBS
- Firm FEI
- 3006241029
- Firm city
- Waltham
- Firm state
- MA
- 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