—#151455

Product

MOSAIQ Oncology Information System The product is used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be use wherever radiotherapy and chemotherapy are prescribed.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K141572
Affected lot / code info: Versions 2.60 an higher

Why it was recalled

Edits to Particle field definition parameters may not be saved when the field definition window is saved.

Root cause (FDA determination)

Software design

Action the firm took

The firm, Elekta, sent an "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" letter dated 11/2016 was sent to affected customers on 12/2/2016. The letter describes the product, problem and actions to be taken. The customers were instructed to save and re-open the field definition form when manual edits have been performed to confirm that the edits were save; post this notice in a place accessible to all users; advise the appropriate personnel working with the product the content of the letter; and complete and return the Acknowledgement Form via fax to: 408 830 8003 immediately upon receipt but no later than 30 days. Elekta will resolve the problem with the MOSAIQ 2.60 SP7F, MOSAIQ 2.60 SP14 and 2.64 SP3. Customers are encouraged to contact Elekta support to get the corrected version. If you have any questions, contact RA Manager Americas at 1-770-300-9725 or email to: Elekta_Global_PMS@elekta.com.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter NE, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern: Worldwide Distribution-US (nationwide) to states of: FL, IL, MO, NJ, OH, OK, TN, TX, VA, and countries of: Italy, Japan, South Korea, Sweden and United Kingdom.

Timeline

Recall initiated: 2016-12-02
Terminated: 2021-11-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #151455. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.