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, Musculo-skeletal Conventional and musculo-skeletal Superficial Applications. The system also provided the ability to measure anatomical structures and calculation packages that provide information to the clinician that my be used adjunctively and with other medical data obtained by a physician for clinical diagnosis purposes.
Recall
- Recall Number
- Z-0824-2014
- Event Number
- 67209
- Firm
- Siemens Medical Solutions USA, Inc.
- FEI Number
- 2936884
- Product Code
- IYN
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- December 22, 2013
- Posted
- January 24, 2014
- Terminated
- May 6, 2015
- Address
- 685 E Middlefield Rd, Mountain View, CA, 94043-4045
Description
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, Musculo-skeletal Conventional and musculo-skeletal Superficial Applications. The system also provided the ability to measure anatomical structures and calculation packages that provide information to the clinician that my be used adjunctively and with other medical data obtained by a physician for clinical diagnosis purposes.
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.
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. If you have any questions, please contact your local service support person for information regarding timelines and status. Until the necessary repairs have been completed on your system, please share this information with all personnel within your organization will need to be aware of thls issue. As always, patient safety issues are a high priority, and we thus alert customers of product concerns which may occur undervarlous conditions. To date, no patient injury has been reported. This problem was discovered as part of our ongoing quality process. We sincerely regret any inconvenience this condition may cause in your daily operations. For further questions please call (650) 694-5398.
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