Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical XRay System 의 리콜

Recall

75575

Class 2

Z-0680-2017

2016-10-27

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150838

Possible unintentional x-ray emission after users attempt early termination of the sequence.

The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 41 units located in the United States will consist of the following: 1. Shipments were stopped until a software correction was designed and validated. The software correction was designed by October 27, 2016, and was implemented on November 7, 2016 for all units that had not left the place of manufacture and for all new products. 2. The software correction will be made available to all distributors, sales personnel and users. Issue 1 is corrected by altering the behavior of the stop button and trigger such that they stop the current test and terminate the test sequence. To correct issue 2 the software will be modified to grey-out the Stop button during this very small period making it consistent with rest of the VANTA Start/Stop test UI paradigm. Both during user Start and Stop actions, users are shown a greyed button to acknowledge user Click and the button is un-greyed when the system completes the user operation. Both user operations typically take 100  400 milliseconds to complete. 3. All VANTA units in the United States are currently in the possession of Olympus or your distributors. No units are in the possession of users. 4. Olympus or its distributors will apply the software correction prior to delivering a VANTA system to any purchasers in the United States. For further questions, please call (781) 419-3900.