Device Recall DELTA XRF analyzer 의 리콜

Recall

73251

Class 2

Z-0803-2016

2016-01-13

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143625

The firm has discovered a software bug.

Olympus Scientific Solutions Americas ( OSSSA) planned action to bring product into compliance: Notification will be given to purchasers per 21 CFR 1003.21. A software modification will be made available to all users contacted. The letter to affected purchasers makes clear that the product will be brought into compliance without charge and offers the purchaser several options for applying the software update. CDRH approves the CAP subject to the following conditions: 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- controlled downloads, follow-up email reporting, return-mail card or some other similarly effective means. For further questions you may call : (866) 446-6689.