CLASS II ONGOING Device recall · Reported 10 Aug 2016 · FDA Enforcement Report

Olympus Scientific Solutions Americas Corporation (Ossa) Model recalled

Olympus Scientific Solutions Americas is recalling Olympus Scientific Solutions Americas Corporation (Ossa) Model, distributed nationwide in the US. The recall was initiated on 22 Jun 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Models of the Delta XRF Analyzer with Software version 2.5.17.1 and higher

Quantity recalled2, 210 units distributed in the USA

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2255-2016
FDA event ID: 74593
Recalling firm: Olympus Scientific Solutions Americas, Waltham, MA
Classification: Class II
Status: Ongoing
Recall initiated: 22 Jun 2016
FDA classified: 29 Jul 2016
Reported: 10 Aug 2016
Type: FDA Mandated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

22 Jun 2016	Recall initiated by company
29 Jul 2016	Classified by FDA	+37 days
10 Aug 2016	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

All Models of the Delta XRF Analyzer with Software version 2.5.17.1 and higher

Where was it sold?

Nationwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Reported	Class	Recall	Company	Reason	Where
9 Aug 2017Device	CLASS II	Olympus Scientific Solutions Americas Corporation (Ossa) Model recalled	Olympus Scientific Solutions Americas	Device Malfunction	Nationwide
8 Feb 2017Device	CLASS II	(Ossa) Vanta¿ Xrf Analyzer recalled by Olympus Scientific Solutions	Olympus Scientific Solutions Americas	Other	22 states
14 Dec 2016Device	CLASS II	Olympus Scientific Solutions Americas Corporation (Ossa) Model recalled	Olympus Scientific Solutions Americas	Other	16 states
2 Mar 2016Device	CLASS II	( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system recalled	Olympus Scientific Solutions Americas	Device Malfunction	Nationwide
12 Aug 2015Device	CLASS II	Analytical X-ray System recalled by Olympus Scientific Solutions	Olympus Scientific Solutions Americas	Foreign Material	Nationwide

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