Recall record at a glance
| Official record | Z-1065-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Report date | Mar 21, 2018 |
| Recall initiation date | Jan 26, 2018 |
| Quantity | 564 systems |
| Location | Mountain View, CA, United States |
Official product description
ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Why the product was recalled
The application may underestimate the EROA (Effective Regurgitant Orifice Area) in comparison to the same patient results obtained with the 4Z1c volume transthoracic echocardiography transducer.
Distribution information
Worldwide Distribution - U.S. nationwide and the countries of Algeria, Argentina, Australia, Austria, Azerbaijan, Brazil, Brunei, Canada, Chile, China, Columbia, Ecuador, Egypt, El Salvador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Malaysia, Malta, Mexico, Netherlands, Norway, Pakistan, Philippines, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, U.A.E, Ukraine, United Kingdom, United States, Uzbekistan, and Vietnam.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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