Z-1991-2015Class II

Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta Element, Delta Plus...

Name: Z-1991-2015 Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta Element, Delta Plus...
Creator: Olympus Scientific Solutions Americas
Published: 2015-06-09
License: https://open.fda.gov/license/

Evident Scientific MIS, Inc. / initiated 2015-06-09 / Open, Classified

FDA source

Olympus Scientific Solutions Americas began a recall of 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... on 2015-06-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1991-2015
Classification: Class II
Status: Open, Classified
Initiated: 2015-06-09
Posted: 2015-07-31
Recalling firm: Evident Scientific MIS, Inc.
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.
Product code: RBS Industrial X-Ray
Reason for recall: 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).
FDA 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 in commerce: 1047
Distribution: Nationwide Distribution.
Product codes and lots: Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1991-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1991-2015	Class II	Ongoing	Voluntary: Firm initiated	2015-08-12	2015-07-31

Product code RBS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)