Z-2255-2016Class II

Olympus Scientific Solutions Americas Corporation (OSSA) Model: Analytical X-Ray System X -Ray Fluorescence...

Name: Z-2255-2016 Olympus Scientific Solutions Americas Corporation (OSSA) Model: Analytical X-Ray System X -Ray Fluorescence...
Creator: Olympus Scientific Solutions Americas
Published: 2016-06-22
License: https://open.fda.gov/license/

Evident Scientific MIS, Inc. / initiated 2016-06-22 / Open, Classified / root cause: software

FDA source

Olympus Scientific Solutions Americas began a recall of Olympus Scientific Solutions Americas Corporation (OSSA) Model: Analytical X-Ray System X -Ray Fluorescence. Intended to emit ionizing radiation Delta with... on 2016-06-22. FDA classified it as Class II and gives the reason as "Trigger lock option does not always prevent x-ray generation. Specifically if the unit is in test mode or repeat test mode then the trigger lock may not prevent x-ray initiation when the trigger is pulled. The...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2255-2016
Classification: Class II
Status: Open, Classified
Initiated: 2016-06-22
Posted: 2016-07-29
Recalling firm: Evident Scientific MIS, Inc.
Product: Olympus Scientific Solutions Americas Corporation (OSSA) Model: Analytical X-Ray System X -Ray Fluorescence. Intended to emit ionizing radiation Delta with models: DC-2000, DC-4000, DC-6000, DI-2000, DP-2000, DP-4000, DP-4050, DP- 6000, DPO-4000, DPO-6000, DS-2000, DS-4000, DS-6000, DS-6500, Delta, Delta 50, Delta Classic Plus, Delta Element, Delta Premium , Delta Professional , and Delta-Pl us.
Product code: RBY X-Ray Fluorescence
Reason for recall: Trigger lock option does not always prevent x-ray generation. Specifically if the unit is in test mode or repeat test mode then the trigger lock may not prevent x-ray initiation when the trigger is pulled. The correction is via repair by a software update.
Root cause tag: software
FDA root cause: Radiation Control for Health and Safety Act
Action: The firm notified customers via an "Important - Electronic Product Radiation Warning" letter. It described the issue; and, told customers to not rely on the Trigger Lock feature until the software upgrade had been completed. The letter also provided instructions for customers to not only determine their software version; but, also instructions to bring their affected device into compliance. The firm will remedy the issue without charge. Customers can contact their local representative or OSSA at [email protected], phone: +1 866 446 6689, fax: +1 781 419 3980, with questions or if additional information is needed.
Quantity in commerce: 2, 210 units distributed in the USA
Distribution: Nationwide Distribution.
Product codes and lots: All Models of the Delta XRF Analyzer with Software version 2.5.17.1 and higher

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2255-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2255-2016	Class II	Ongoing	FDA Mandated	2016-08-10	2016-07-29

Product code RBY

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)