Z-2255-2016 Class II Ongoing

Recalled by Olympus Scientific Solutions Americas — Waltham, MA

Recall Details

Product Type
Devices
Report Date
August 10, 2016
Initiation Date
June 22, 2016
Termination Date
N/A
Voluntary/Mandated
FDA Mandated
Product Quantity
2, 210 units distributed in the USA

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.

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.

Distribution Pattern

Nationwide Distribution.

Code Information

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