FDA Medical Device Recalls (openFDA)
Elekta, Inc.: MOSAIQ Oncology Information System
- Recall number
- Z-2917-2018
- Recalling firm
- Elekta, Inc.
- Product
- MOSAIQ Oncology Information System
- Status
- Terminated
- Initiated
- 2018-08-03
- Posted
- not on file
- Terminated
- 2024-09-23
- Reason
- Order Status Remains Approved When Should Indicate Complete.
- Root cause
- Unknown/Undetermined by firm
- Action
- On August 2018 the firm sent letter to all their customer with the following instructions; Recommended User Action: A user with appropriate pharmacy rights can unlock the record. This blanks out the details requiring the user to re-enter the administration details previously entered. To avoid this locking issue, close the MAR window before navigating to the CWS. This document contains important information for the continued safe and proper use of your equipment. Please post this notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed. Advise the appropriate personnel working with this product the content of this letter. Elekta Corrective Actions: The issue is resolved in MOSAIQ Release 2.65 Beta 02 and in release 2.64 SP10. In order to meet regulatory requirements, you are required to complete this the Acknowledgement Form and return it to Elekta immediately upon receipt but no later than 30 days.
- Quantity
- 185
- Distribution
- AK, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, WA, WI, WV, and WY Australia, Canada, Ireland, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, and United Kingdom
- Lot, serial or model codes
- Software Build(s) 2.64 SP3 and higher
- 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