Class 2 Device Recall LANTIS Oncology Information System

• Date Initiated by Firm: August 21, 2009
• Date Posted: April 13, 2011
• Recall Status: Terminated on April 13, 2011
• Recall Number: Z-1970-2011
• Recall Event ID: 53195
• 510(K)Number: K031764 K060226 K072485 K993425
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: 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.
• Code Information: versions 8.3, CD# 9, 10 and 11, part numbers 8149259, 8164787, 8166527
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 4040 Nelson Ave; Concord CA 94520-1200
• For Additional Information Contact: Christine Dunbar; 925-246-8407
• Manufacturer Reason for Recall: When editing the note type of a previously entered note, then reverting to the original type, data may be lost.
• FDA Determined Cause: Software design
• Action: Siemens sent an Urgent Medical Device Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to configure their system to lock all new notes automatically. To automatically lock new notes, open eChart Navigator, right mouse click in the notes section, select "configuration" and select "Automatically Lock New Notes." If the customer chooses not to configure their system to automatically lock new notes, follow at least one of the suggestions listed below: If the customer must edit a note type, use the append feature and document that they are making an edit to the note. Lock all new notes that are entered via eChart Notes. To lock a note manually, after creating the note, right mouse click and select "Lock," Access and enter patient notes via eChart Notes until a LANTIS upgrade has been performed at your site. When entering patient notes via eChart Navigator, make sure that you are entering the notes in the correct section.\ When entering patient notes via eChart Notes, make sure that the correct note type has been selected. Customers are to keep the Customer Safety Advisory Notice together with their LANTIS 8.30 User Manual where it should remain until the measures defined above are performed. For questions call 1-888-826-9702.
• Quantity in Commerce: 30 affected units
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IYE and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.