Z-0803-2016Class II

Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray...

Name: Z-0803-2016 Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray...
Creator: Olympus Scientific Solutions Americas
Published: 2016-01-13
License: https://open.fda.gov/license/

Evident Scientific MIS, Inc. / initiated 2016-01-13 / Terminated / root cause: software

FDA source

Olympus Scientific Solutions Americas began a recall of Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system on 2016-01-13. FDA classified it as Class II and gives the reason as "The Firm has discovered a Software bug". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0803-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-13
Posted: 2016-02-19
Terminated: 2021-05-18
Recalling firm: Evident Scientific MIS, Inc.
Product: Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system
Product code: RBY X-Ray Fluorescence
Reason for recall: The Firm has discovered a Software bug.
Root cause tag: software
FDA root cause: Radiation Control for Health and Safety Act
Action: Olympus Scientific Solutions Americas ( OSSSA) planned action to bring product into compliance: Notification will be given to purchasers per 21 CFR 1003.21. A software modification will be made available to all users contacted. The letter to affected purchasers makes clear that the product will be brought into compliance without charge and offers the purchaser several options for applying the software update. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Tracking of customer/owner self-installation(s) of the software update should be done to the maximum possible extent via serial-number- controlled downloads, follow-up email reporting, return-mail card or some other similarly effective means. For further questions you may call : (866) 446-6689.
Quantity in commerce: US - 5000 units
Distribution: Worldwide Distribution - USA (nationwide) Distribution
Product codes and lots: All models of the Delta XRF Analyzer

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0803-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0803-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-19

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)