GE Healthcare recall
GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows easy selection…
Why was GE Healthcare recalled?
GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. This issue may result in a potential miscalculation of size.
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?
000000010005GS 000000010004GS 000000010009GS 000000010007GS 000000010006GS 000000010010GS 000000010001GS 000000010002GS 000000010008GS 000000010003GS 00000L3A4391A7 00000L3A8D5CF0
- Product
- GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows easy selection…
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 12
- Distribution
- Worldwide Distribution -- USA (nationwide) including states of: CA, CT, NY, TX, and MS and countries of TAIWAN, ITALY, CANADA, and BAHRAIN
- Recall date
- October 31, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)