FDA Medical Device Recalls (openFDA)
Olympus Scientific Solutions Americas: Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system
- Recall number
- Z-0803-2016
- Recalling firm
- Olympus Scientific Solutions Americas
- Product
- Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system
- Status
- Terminated
- Initiated
- 2016-01-13
- Posted
- not on file
- Terminated
- 2021-05-18
- Reason
- The Firm has discovered a Software bug.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- 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.
- Quantity
- US - 5000 units
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution
- Lot, serial or model codes
- All models of the Delta XRF Analyzer
- 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