Siemens brand ACUSON SC2000 Ultrasound System recall
Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200; The SC2000 ultrasound…
Why was Siemens brand ACUSON SC2000 Ultrasound System recalled?
When using the V5M transducer, the display of the temperature on the ACUSON SC2000 system can be lower than the actual temperature of the V5M transducer. This occurs only if the system hardware contains revision 4 of the MPI Board. There is a potential to cause esophageal burns in patients.
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?
All units of this model.
- Product
- Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200; The SC2000 ultrasound…
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Quantity
- 120 units
- Distribution
- Worldwide Distribution - USA and countries of Australia, Austria, Bosnia Herzegovina, Belgium, Finland, France, Germany, India, Italy, Japan, Kuwait, Malaysia, Netherlands, Norway, P.R. China, Portugal, Rep.of Korea, Romania, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan and United Kingdom.
- Recall date
- April 17, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)