SIGNA Creator recall
SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
Why was SIGNA Creator recalled?
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
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?
Software version DV29.1
- Product
- SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 6 devices
- Distribution
- Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, UAE, and UK
- Recall date
- October 27, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)