FDA Device recall Z-2255-2016

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

• FDA Device
• Class II
• ongoing
• Published 2016-08-10

On 2016-08-10 the FDA classified a Class II recall of Olympus Scientific Solutions Americas Corporation (OSSA) Model: Analytical X-Ray System X -Ray Fluorescence by Olympus Scientific Solutions Americas, citing 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 w….

Read the official FDA Device notice

Product

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.

Reason

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2255-2016%22

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