GE Healthcare Senographe Essential System. The recall
GE Healthcare Senographe Essential System. The Senographe 2000D system generates digital mamnmographic images that can be used for screening and in…
Why was GE Healthcare Senographe Essential System. The recalled?
GE Healthcare has recently become aware of a potential issue due to inaccessible Operator Instructions associated with the defective Operator Manual CD of the Senographe Essential.
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?
Models 5144816-10 rev 2, 3 or 6 and 5144816-10-LE rev1.
- Product
- GE Healthcare Senographe Essential System. The Senographe 2000D system generates digital mamnmographic images that can be used for screening and in…
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 49 installed in the US.
- Distribution
- Nationwide Distribution including the states of NJ, CO, LA, AL, OH, MA, NC, ME, WI, GA, PA, TX, IN, NY, MO, KY, KS, CA, MN, FL and IL.
- Recall date
- July 3, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)