MOSAIQ MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It support
FDA device recall Z-1869-2014 · posted 2014-06-25 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- MOSAIQ does not re-calculate the agent volume when the user changes the ordering dose (to other than what was calculated) prior to saving the order.
- Action taken
- Elekta issued an Important Safety Notice dated May 29, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Corrective action that shall be taken: Notify the affected customers of the issue - To be completed 06/22/2014 Follow up with the affected customers for: Confirmation receipt of the LIN, AND Confirmation of installation of patch for the fix- To be completed 11/30/2014 The notice includes a confirmation which is to be returned. For further questions call (770) 670-2422.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 101
- Distribution
- Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AL, AK, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, KY, LA, ME, MD, MA, MI, MO, MT, NH, NJ, NM, NY, NC, ND, OH, OK, OR
- Date initiated
- 2014-05-29
- Date posted
- 2014-06-25
- Date terminated
- 2021-07-16
- Location
- Atlanta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MOSAIQ ONCOLOGY INFORMATION SYSTEM (K123230) | Impac Medical Systems, Inc. | 2012-12-12 |