Olympus Analytical X-Ray Systems Recalled for Trigger Lock Failure
Olympus Scientific Solutions Americas is recalling Analytical X-Ray Systems because the trigger lock may fail to prevent x-ray generation in test modes.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a defect that allows unintended ionizing radiation emission, which constitutes a significant injury risk.
Plain-English summary
Olympus Scientific Solutions Americas Corporation (OSSA) is recalling specific models of its Analytical X-Ray Systems, including the 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-Plus. The recall involves 2,210 units distributed nationwide in the United States. The affected units are identified by having software version 2.5.17.1 or higher.
The recall is being issued because the trigger lock option does not always prevent x-ray generation. Specifically, if the unit is in test mode or repeat test mode, the trigger lock may not prevent x-ray initiation when the trigger is pulled. This defect poses a risk of unintended ionizing radiation exposure.
The correction for this issue is a software update repair. Users of these systems should contact Olympus Scientific Solutions Americas to arrange for the necessary software update to ensure the trigger lock functions correctly.
The recalled product
- 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…
- Manufacturer
- Olympus Scientific Solutions Americas
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Models of the Delta XRF Analyzer with Software version 2.5.17.1 and higher
Distribution
Distributed nationwide across the United States.
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