Z-0680-2017Class II

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

Name: Z-0680-2017 Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System
Creator: Olympus Scientific Solutions Americas
Published: 2016-10-27
License: https://open.fda.gov/license/

Evident Scientific MIS, Inc. / initiated 2016-10-27 / Terminated

FDA source

Olympus Scientific Solutions Americas began a recall of Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System on 2016-10-27. FDA classified it as Class II and gives the reason as "Possible unintentional x-ray emission after users attempt early termination of the sequence". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0680-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-27
Posted: 2016-12-07
Terminated: 2020-07-30
Recalling firm: Evident Scientific MIS, Inc.
Product: Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System
Product code: RBY X-Ray Fluorescence
Reason for recall: Possible unintentional x-ray emission after users attempt early termination of the sequence.
FDA root cause: Radiation Control for Health and Safety Act
Action: The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 41 units located in the United States will consist of the following: 1. Shipments were stopped until a software correction was designed and validated. The software correction was designed by October 27, 2016, and was implemented on November 7, 2016 for all units that had not left the place of manufacture and for all new products. 2. The software correction will be made available to all distributors, sales personnel and users. Issue 1 is corrected by altering the behavior of the stop button and trigger such that they stop the current test and terminate the test sequence. To correct issue 2 the software will be modified to grey-out the Stop button during this very small period making it consistent with rest of the VANTA Start/Stop test UI paradigm. Both during user Start and Stop actions, users are shown a greyed button to acknowledge user Click and the button is un-greyed when the system completes the user operation. Both user operations typically take 100 400 milliseconds to complete. 3. All VANTA units in the United States are currently in the possession of Olympus or your distributors. No units are in the possession of users. 4. Olympus or its distributors will apply the software correction prior to delivering a VANTA system to any purchasers in the United States. For further questions, please call (781) 419-3900.
Quantity in commerce: 41 units
Distribution: US Distribution to the states of : TX, WA, GA, MA, SC, AZ, PA, VA, CA, OH, NJ, MD, CO, IL, LA, and MN.
Product codes and lots: Model - Vanta VCR

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0680-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0680-2017	Class II	Terminated	FDA Mandated	2016-12-14	2016-12-07

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)