Recall Z-1597-2020— Elekta Impac Software

Name: FDA recall Z-1597-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-24

Class II · Ongoing

Class II FDA medical device recall by Elekta Impac Software, initiated 2019-09-24. It names one FDA 510(k) clearance: K141572. Product: MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.. Reason: The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units..

Recalling firm: Elekta Impac Software
Classification: Class II
Status: Ongoing
Initiated: 2019-09-24
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K141572 — MOSAIQ ONCOLOGY INFORMATION SYSTEMImpac Medical Systems, Inc.·cleared 2014-09-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.

Reason for recall

The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.

Data sourced from openFDA. This site is unofficial and independent of the FDA.