Recall Z-0824-2014 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
ACUSON SC2000 Ultrasound System; Power Input: 100-240VAC, 1600W Max, 50/60 Hz. Manufacturer: Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 SC2000 ultrasound imaging system is intended for Cardiac, neo-natal and fetal cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal interoperative, Intraoperative Neurological, Mus
| Date | Jan 24, 2014 (initiated Dec 22, 2013) |
| Status | Terminated |
| Reason | The user interface assembly on the ACUSON SC2000 may become loose with the potential for the entire module to fall off of the ultrasound system. |
| Root cause | Nonconforming Material/Component |
| Action | Siemens sent an Customer Safety Advisory Notification letter on December 22, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed to:. If you observe looseness in the attachment of the user interface module to the column on the ultrasound system, immediately stop using your system and contact your Siemens service representative for repair. Your local Customer Service Engineer will contact you to make the necessary repairs on your system. You will be contacted to schedule an appointment. |
| Quantity | 843 active units |
| Distribution | Worldwide Distribution - US (nationwide) and the countries of Albania, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Brunei, Canada, Columbia, Denmark, Ecuador, Egypt, Finland, France, Germany, Iceland, India, Israel, Italy, Japan, Kuwait, Malaysia, Mauritius, Mexico, Netherlands, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123622 | ACUSON Siemens Medical Solutions USA, Inc., Dec 5, 2012 |