SIGNA Architect system Product Usage: The Signa recall
SIGNA Architect system Product Usage: The Signa Architect system is a whole body magnetic resonance scanner designed to support high resolution, high…
Why was SIGNA Architect system Product Usage: The Signa recalled?
A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used.
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?
Model number: 5388807-100, Serial number (System ID number ): U30RF0251B (801588MR3), U30RF0258B (M4040093), U30RF0275B (850270504), U30RF0268B (A020MR05)
- Product
- SIGNA Architect system Product Usage: The Signa Architect system is a whole body magnetic resonance scanner designed to support high resolution, high…
- Recalling firm
- GE Medical Systems, LLC
- Quantity
- 4 units
- Distribution
- Worldwide - US Nationwide Distribution in the state of Utah. International distribution to France, Republic of Korea, and Sweden.
- Recall date
- October 31, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)