Recalls / —
—#166796
Product
MOSAIQ Oncology Information System
- FDA product code
- IYE — Accelerator, Linear, Medical
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K141572
- Affected lot / code info
- Software Build(s) 2.64 SP3 and higher
Why it was recalled
Order Status Remains Approved When Should Indicate Complete.
Root cause (FDA determination)
Unknown/Undetermined by firm
Action the firm took
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.
Recalling firm
- Firm
- Elekta, Inc.
- Address
- 400 Perimeter Center Ter NE, Ste 50, Atlanta, Georgia 30346-1227
Distribution
- Distribution pattern
- 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
Timeline
- Recall initiated
- 2018-08-03
- Terminated
- 2024-09-23
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #166796. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.