Device Recall VANTA Analytical XRay System, X Ray Fluorescence 의 리콜

Recall

77759

Class 2

Z-2760-2017

2017-07-11

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157835

Instruments may, under certain specific circumstances listed below, fail to stop when a test is initiated and no sample is present (proximity shut down fails to end test).

Olympus Scientific Solutions Americas Corp will bring defect into compliance: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Tracking of customer/owner self-installation(s) of the software update should be done to the maximum possible extent via serial-number-tracked downloads, follow-up email reporting, return- mail card or by other similarly effective means. For further questions, please call (781) 419-3900.