Olympus Scientific Solutions Americas: Medical Device Recall in 2016 - (Recall #: Z-2255-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 22, 2016

Date Posted: August 10, 2016

Recall Number: Z-2255-2016

Event ID: 74593

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.

Status: Ongoing

Product Quantity: 2, 210 units distributed in the USA

Code Information:

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

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

FDA Mandated