Recall Z-0821-2019— Elekta, Inc.
Class II · Ongoing
Class II FDA medical device recall by Elekta, Inc., initiated 2018-12-13. It names 4 FDA 510(k) clearances: K141572, K123230, K120067 and 1 more. Product: MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.. Reason: There is a potential that Wedge IDs were not included in the DICOM RT PLAN sent from the TPS, which will cause the field in MOSAIQ to be created with no wedge. Treatment of a field without the planned wedge will receive more dose than the treatment plan indicates..
- Recalling firm
- Elekta, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2018-12-13
- Firm location
- Atlanta, GA, United States
510(k) clearances named in this recall
4 on FDA's record- K141572 — MOSAIQ ONCOLOGY INFORMATION SYSTEM
- K123230 — MOSAIQ ONCOLOGY INFORMATION SYSTEM
- K120067 — MOSAIQ ONCOLOGY INFORMATION SYSTEM
- K981313 — SEQUENCER
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 and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
Reason for recall
There is a potential that Wedge IDs were not included in the DICOM RT PLAN sent from the TPS, which will cause the field in MOSAIQ to be created with no wedge. Treatment of a field without the planned wedge will receive more dose than the treatment plan indicates.
Data sourced from openFDA. This site is unofficial and independent of the FDA.