ACUSON SC2000 Ultrasound System. The firm name on the recall
ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
Why was ACUSON SC2000 Ultrasound System. The firm name on the recalled?
The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.
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 versions VB20A, VB20B, or VB20C that have a common physio module (CPM) (known by customers as the ECG (physio) hardware) installed at revision 4
- Product
- ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Quantity
- 229 systems
- Distribution
- Distribution was made to medical facilities in AZ, CA, CT, FL, IL, IN, KS, KY, MI, MN, MO, NJ, NY, NC, OH, PA, TX, VA, and WA. There was no military/government distribution. Foreign distribution was made to Argentina, Australia, Austria, Belgium, Bosnia Herzeg, Colombia, Croatia, Denmark, France, Germany, India, Ireland, Israel, Italy, Japan, Mexico, New Zealand, Philippines, Poland, Republic Korea, Romania, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, and Vietnam.
- Recall date
- May 16, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)