FDA Medical Device Recalls (openFDA)
Elekta, Inc.: MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
- Recall number
- Z-0447-2016
- Recalling firm
- Elekta, Inc.
- Product
- MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
- Status
- Terminated
- Initiated
- 2015-11-24
- Posted
- not on file
- Terminated
- 2021-09-15
- Reason
- First Databank (FDB) is a third party product incorporated into MOSAIQ. FDB routinely modifies drugs in their database to reflect market and formulary changes. In FDB Framework v2.0, those drugs are not being included in drug-drug, drug-allergy and duplicate drug therapy interaction checking.
- Root cause
- Software design
- Action
- Elekta sent an Urgent Important Field Safety Notice 371-01-MSQ-004 to all affected customers on 11/24/2015. The notice informs users to the issue, the work around and the solution. The customers are instructed to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta Office or Representative, as soon as possible but no longer than 30 days from receipt.
- Quantity
- 211
- Distribution
- Nationwide Distribution -- AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, & Puerto Rico.
- Lot, serial or model codes
- Versions prior to 2.60.
- 510(k) numbers
- ["K141572"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 1037831
- Firm city
- Atlanta
- Firm state
- GA
- 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