Device recall: Olympus Scientific Solutions Americas Corporation (“OSSA”) Model: Analytical X-Ray System X -Ray Fluorescence.…
Class II FDA enforcement event 74593. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Olympus Scientific Solutions Americas started this device recall on 22 Jun 2016. The firm address in the FDA record is in Waltham, MA. FDA put the recall in Class II. FDA event 74593 has 1 product record. The first FDA enforcement report date is 10 Aug 2016. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide Distribution.
Recalling firm
Olympus Scientific Solutions Americas, Waltham, MA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: FDA Mandated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2255-2016 | 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… | 2, 210 units distributed in the USA | Class II | Ongoing | 10 Aug 2016 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2016
- 1,232
- Share of these events in Class II
- 91%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 11 Jul 2017 | Olympus Scientific Solutions Americas Corporation (“OSSA”) Model: VANTA Analytical X-Ray System, X-Ray Fluorescence | Device | Class II | 1 |
| 7 Jan 2017 | Olympus Scientific Solutions Americas Corporation (“OSSA”) VANTA XRF Analyzer. Model Vanta VCR and Vanta VMR Analytical | Device | Class II | 1 |
| 27 Oct 2016 | Olympus Scientific Solutions Americas Corporation (“OSSA”) Model: VANTA Analytical X-Ray System | Device | Class II | 1 |
| 13 Jan 2016 | Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system | Device | Class II | 1 |
| 9 Jun 2015 | Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM- | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-2255-2016The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 74593. https://recallregister.com/fda/ii/74593/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide Distribution.
- What quantity of product is in FDA event 74593?
- The FDA record gives this quantity:
2, 210 units distributed in the USA
- How did the recall start?
- The FDA record says:
FDA Mandated
- How many device recalls of 2016 have the same class?
- 91% of the 1,232 device events that started in 2016 are in Class II.