ACUSON SC2000 Ultrasound System; Power Input: 100-240VAC, 1600W Max, 50/60 Hz. Manufacturer: Siemens Medical Solutions U
FDA device recall Z-0824-2014 · posted 2014-01-24 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 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, Franc
- Date initiated
- 2013-12-22
- Date posted
- 2014-01-24
- Date terminated
- 2015-05-06
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUSON (K123622) | Siemens Medical Solutions USA, Inc. | 2012-12-05 |