Product Wiki · Recalls · U.S. FDA — Device Enforcement

Olympus Scientific Solutions Americas Corporation ( OSSA ) Model… — recall Z-2255-2016

U.S. FDA — Device Enforcement · United States · 2016-06-22 · Class II

As described by U.S. FDA — Device Enforcement: 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, D

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2255-2016
Date of alert
2016-06-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Olympus Scientific Solutions Americas
Product category
device
Product type
Devices
Recall status
Ongoing — the recall is still in progress
Initiated by
FDA Mandated
Distribution
Nationwide Distribution.
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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