Recalls / —

—#174163

Product

iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2

FDA product code

IYE — Accelerator, Linear, Medical

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K072079

Affected lot / code info

Version 2.2.0, Product Code/GTIN Number: 04056719001704;   Version 2.2.1, Product Code/GTIN Number: 04056719001742;   Version 2.2.2, Product Code/GTIN Number: 04056719002039

Why it was recalled

Potential for iGUIDE to incorrectly monitor the 3D position.

Root cause (FDA determination)

Software Design Change

Action the firm took

Elekta, Inc. notified customers on about 06/19/2019 via URGENT IMPORTANT FIELD SAFETY NOTIFICATION" letter. Customers were instructed to follow the below steps: 1. Log on to iGUIDE and move the 3D position. If the 3D position is equal to the PARK position, the system is not affected. 2. If the 3D position is not equal to the PARK position, log on to iGUIDE with Operator and Administrator rights. (If no user is available, go to the iGUIDE User Manager and add an appropriate user.). 3. Move the HexaPOD to the 3D Position (If 3D position is equal to the DRIVE position, both checkmarks will appear). 4. Open the HexaPOD properties (Left click the HexaPOD symbol on the system overview), which will display the HexaPOD properties. 5. Enter a rotation of 1.00 degree for any of the axis (RX, RY, RZ) and click Go to position. 6. Execute the pending movement. If the checkmark for the 3D position disappears and the EXTERNAL INHIBIT is set, your system is not affected by the comma / dot issue. No further actions are necessary. If the 3D position monitoring does not consider the 1.00 degree and the checkmark for the 3D position is still displayed and the EXTERNAL INHIBIT is not set, your system is affected! If the customer wants to still use a 3D workflow without imaging, do not rely on the 3D position indicator in iGUIDE. The HexaPOD should be moved to the PARK position first, then the 3D workflow can be started moving the HexaPOD back to the 3d position. Customers were also instructed to place the recall notice in a place accessible to all users (e.g. Instructions for Use, until this action is closed) and to advise the appropriate personnel, working with this product, on the content of this letter. A technical solution (iGUIDE patch) will be provided to correct the behavior. Until the iGUIDE patch is available, an interim solution can be implemented (change comma to dot) if your system is affected. Please consult your local Elekta represent

Recalling firm

Firm

Elekta, Inc.

Address

400 Perimeter Center Ter NE, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern

Nationwide distribution to AK, AL, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI. Worldwide distribution to Algeria, Argentina, Australia, Austria, Belgium, Botswana, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Vietnam.

Timeline

Recall initiated

2019-06-19

Terminated

2024-05-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #174163. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.