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Terminated

MOSAIQ Oncology Information System

FDA Recall Z-2917-2018 · Posted None

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2018-08-03
Date Terminated2024-09-23
Product Quantity185

Reason for Recall

Order Status Remains Approved When Should Indicate Complete.

Firm Action

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.

Root Cause

Unknown/Undetermined by firm

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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