Evident Scientific MIS, Inc.
Needham, MA, US
Evident Scientific MIS, Inc. appears in FDA device records in Needham, MA. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Evident Scientific MIS, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Olympus Scientific Solutions Americasenforcement report, recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006241029 | 3006241029 | Evident Scientific MIS, Inc. | 140 Kendrick St, Needham, MA 02494 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2760-2017 | Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System, X-Ray Fluorescence | Instruments may, under certain specific circumstances listed below, fail to stop when a test is initiated and no sample is present (proximity shut down fails to end test). | Class II | Terminated | |
| Z-1036-2017 | Olympus Scientific Solutions Americas Corporation (OSSA) VANTA XRF Analyzer. Model Vanta VCR and Vanta VMR Analytical X-ray systems | 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. | Class II | Terminated | |
| Z-0680-2017 | Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System | Possible unintentional x-ray emission after users attempt early termination of the sequence. | Class II | Terminated | |
| 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 Classic Plus, Delta Element, Delta Premium , Delta Professional , and Delta-Pl us. | 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 | Open, Classified | |
| Z-0803-2016 | Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system | The Firm has discovered a Software bug. | Class II | Terminated | |
| Z-1991-2015 | Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10. Mobile X-ray System. | Higher than published scatter around the probe head when testing some samples. At the point the customer would interact directly with the instrument (Trigger position), most readings were lower. However, measurements around the probe head were higher particularly on samples know to be highly scattering (plastics, soils) with minimal increases on high density samples (steel, aluminum). | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain