FDA Medical Device Recalls (openFDA)
Olympus Scientific Solutions Americas: Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System
- Recall number
- Z-0680-2017
- Recalling firm
- Olympus Scientific Solutions Americas
- Product
- Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System
- Status
- Terminated
- Initiated
- 2016-10-27
- Posted
- not on file
- Terminated
- 2020-07-30
- Reason
- Possible unintentional x-ray emission after users attempt early termination of the sequence.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- 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.
- Quantity
- 41 units
- Distribution
- US Distribution to the states of : TX, WA, GA, MA, SC, AZ, PA, VA, CA, OH, NJ, MD, CO, IL, LA, and MN.
- Lot, serial or model codes
- Model - Vanta VCR
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RBY
- Firm FEI
- 3006241029
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28