—#84912

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.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K031764, K060226, K072485, K993425
Affected lot / code info: versions 8.3, CD# 9, 10 and 11, part numbers 8149259, 8164787, 8166527

Why it was recalled

When editing the note type of a previously entered note, then reverting to the original type, data may be lost.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 4040 Nelson Ave, Concord, California 94520-1200

Distribution

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.

Timeline

Recall initiated: 2009-08-21
Posted by FDA: 2011-04-13
Terminated: 2011-04-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #84912. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.