FDA Device recall Z-0169-2013
MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management
- FDA Device
- Class II
- terminated
- Published 2012-11-07
On 2012-11-07 the FDA classified a Class II recall of MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management by Elekta, citing A patient was seriously mistreated after a user made and saved an inadvertent change to the definition of a treatment filed in MOSAIQ.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0169-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-18 |
| Published | 2012-11-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Elekta |
| Distribution | US |
Product
MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view, annotate, manipulate, enhance, manage, and archive images.
Reason
A patient was seriously mistreated after a user made and saved an inadvertent change to the definition of a treatment filed in MOSAIQ.
Identifiers
| code_info | Version 2.00 to 2.41 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0169-2013%22
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