LANTIS oncology Information System, an accessory to the Linear Accelerator, as part of the COHERENCE RT Therapist, but also cleared under the ONCOR Avante-Garde and Expression, as well as the syngo RT Therapist system, as part of the ARTISTE And PRIMUS system. Manufactured by IMPAC Medical Inc., Sunnyvale, CA, device distributed by Siemens Medical Solutions Oncology Care System, Concord, CA Electronic record management system as part of a linear accelerator system used to keep track of notes and database for oncology electronic medical records.
FDA Recall Z-1970-2011 · Posted 2011-04-13
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Reason for Recall
Firm Action
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - USA including DE, WI, TX, TN, NJ, PA, NE, MA, and AL and the countries of South Africa, Australia, Ireland, Germany, Brazil, South Korea, India, and Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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