Reported Feb 5, 2014 · Terminated
ACUSON SC2000 Ultrasound System; Power Input: 100-240VAC, 1600W Max, 50/60 Hz. Manufacturer: Siemens Medical Solutions…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc. · 685 E Middlefield Rd · Mountain View, CA · 94043-4045
Is this the product you have?
- ACUSON SC2000 Ultrasound System
- Power Input
100-240VAC1600W Max50/60 Hz
- ManufacturerSiemens 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
- Lot codes and dates
Model number 10433816Serial numbers lower than 401100
- Serial numbers
824 of 824 codes
400935400686400597400833400140400753400752400771401016400166400635400582400983400532400580400592400804400733400737400652401036400643400746400349400784400919400685400777400186400499400896400809400259400282400758400762400831400723400402400633401027400111400319400515400942400793400699400849400816400216400212400713400764400730400734401021400215400735400920401052
- Amount recalled
- 843 active units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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