MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment plann
FDA device recall Z-2063-2015 · posted 2015-07-14 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic plans using cones.
- Action taken
- Elekta sent an Urgent Important Field Safety Notice 371-01-MSQ-003 on July 1, 2015, to all affected customers. The notice informed users of the specific product and version numbers affected and that the problem only exists if all the following criteria is met - (1) Running Mosaiq 2.41; (2) with at least one linac equipped with an Agility 160 MLC head (Versa HD, Infinity, Axesse (EOS) or Synergy); and (3) who are treating with Stereotactic Cones. The notice also advises users of the workaround to avoid the problem. The customers were also instructed to return the Important Field Safety Notice Acknowledgment form. For questions regarding this recall call 770-670-2422.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 74 Total (45 US)
- Distribution
- Worldwide Distribution - US including AZ, CA, GA, ID, IL, MO, NJ, NY, NC, OR, SC, TN, WV, and Internationally to Austria, Brazil, Bulgaria, Canada, Colombia, Germany, Israel, Italy, Japan, Mexico, Rus
- Date initiated
- 2015-07-01
- Date posted
- 2015-07-14
- Date terminated
- 2021-09-15
- Location
- Atlanta, GA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MOSAIQ ONCOLOGY INFORMATION SYSTEM (K141572) | Impac Medical Systems, Inc. | 2014-09-05 |