iGUIDE System with software build iGuide 2.2.0 recall
iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
Why was iGUIDE System with software build iGuide 2.2.0 recalled?
Potential for iGUIDE to incorrectly monitor the 3D position.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
- Recalling firm
- Elekta, Inc.
- Quantity
- 374 devices
- Distribution
- 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.
- Recall date
- August 21, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)