Z-1036-2017Class II

Olympus Scientific Solutions Americas Corporation (OSSA) VANTA XRF Analyzer. Model Vanta VCR and Vanta VMR...

Name: Z-1036-2017 Olympus Scientific Solutions Americas Corporation (OSSA) VANTA XRF Analyzer. Model Vanta VCR and Vanta VMR...
Creator: Olympus Scientific Solutions Americas
Published: 2017-01-07
License: https://open.fda.gov/license/

Evident Scientific MIS, Inc. / initiated 2017-01-07 / Terminated

FDA source

Olympus Scientific Solutions Americas began a recall of Olympus Scientific Solutions Americas Corporation (OSSA) VANTA XRF Analyzer. Model Vanta VCR and Vanta VMR Analytical X-ray systems on 2017-01-07. FDA classified it as Class II and gives the reason as "It was discovered under rare circumstances the LED warning light circuit could fail. If this happens, while the instrument is emitting X-rays during at test, the LED warning lights will not illuminate. The test runs...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1036-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-07
Posted: 2017-02-01
Terminated: 2019-08-27
Recalling firm: Evident Scientific MIS, Inc.
Product: Olympus Scientific Solutions Americas Corporation (OSSA) VANTA XRF Analyzer. Model Vanta VCR and Vanta VMR Analytical X-ray systems
Product code: RBY X-Ray Fluorescence
Reason for recall: It was discovered under rare circumstances the LED warning light circuit could fail. If this happens, while the instrument is emitting X-rays during at test, the LED warning lights will not illuminate. The test runs normally and will execute as before, but the light will not be on.
FDA root cause: Radiation Control for Health and Safety Act
Action: Olympus will bring the defect compliance : 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 recall 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-tracked downloads, follow-up email reporting, return-mail card or by other similarly effective means. For further questions, please call (781) 419-3500.
Quantity in commerce: US 74
Distribution: US Distribution to the states of : PA, MA, CO, OH, NJ, GA, CA, TX, IL, VA, MN, NH, WA, SC, AZ, LA, MD, OK, IN, NY, NC and KS.
Product codes and lots: affects all units.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1036-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1036-2017	Class II	Terminated	FDA Mandated	2017-02-08	2017-02-01

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)