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Terminated

Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System, X-Ray Fluorescence

FDA Recall Z-2760-2017 · Posted None

Recalling FirmOlympus Scientific Solutions Americas
Recall StatusTerminated
Product CodeRBY
Date Initiated2017-07-11
Date Terminated2023-05-03
Product Quantity146 units

Reason for Recall

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).

Firm Action

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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Worldwide Distribution - USA (nationwide) Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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