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U.S. Department of Health and Human Services

Class 2 Device Recall ACUSON SC 2000 ultrasound system

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  Class 2 Device Recall ACUSON SC 2000 ultrasound system see related information
Date Initiated by Firm September 29, 2010
Date Posted December 28, 2010
Recall Status1 Terminated 3 on October 04, 2011
Recall Number Z-0827-2011
Recall Event ID 57289
510(K)Number K072365  
Product Classification System, imaging, pulsed doppler, ultlrasonic - Product Code IYN
Product ACUSON SC 2000 ultrasound system.
Siemens Medical Solutions USA, Inc.
Business Unit Ultrasound
1230 Shorebird Way
Mountain View, CA 94043

Intended use: SC2000 ultrasound system is intended for the following applications: Cardiac, neo-Natal and fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, and anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medial data obtained by a physician for clinical diagnosis purposes.
Code Information Material Number: 10033682: Serial number of systems: 400212 400213 400215 400251 400405 400240 400089 400090 400104 400109 400149 400171 400289 400302 400334 400337 400183 400218 400209 400219 400259 400126 400247 400257 400260 400263 400281 400116 400165 400214 400420 400216 400253 400403 400412 400343 400185 400026 400044 400045 400084 400086 400088 400091 400102 400111 400114 400117 400118 400121 400124 400129 400132 400135 400139 400142 400143 400145 400146 400148 400156 400162 400168 400174 400176 400179 400202 400203 400206 400217 400220 400221 400222 400223 400224 400225 400227 400228 400229 400230 400232 400233 400234 400235 400236 400238 400239 400242 400243 400244 400258 400268 400269 400270 400272 400282 400287 400288 400290 400291 400293 400295 400297 400303 400304 400312 400314 400316 400336 400435 400449 400294 400127 400043 400125 400199 400200 400208 400113 400120 400237 400241 400332 400335 400413 400419 400158 400160 400161 400170 400172 400181 400182 400184 400187 400191 400201 400211 400249 400250 400299 400115 400155 400157 400207 400416 400424 400189 400195 400197 400166 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
P.O. Box 7393
Mountain View CA 94043
For Additional Information Contact Sheila Pickering
650-694-5398
Manufacturer Reason
for Recall		 There is the possibility of a short occurring in the transducer which could cause focal heating on the probe face.
FDA Determined
Cause 2		 Other
Action SIEMENS issued a filed correction in the form of a "Customer Safety Advisory Notification" initiated on September 29, 2010 and mailed to customers by Federal Express on the same day. The notification described the product, problem and actions to be taken by the customers. The customers were instructed to examine the 4Z1c transducer prior to use (Note: if transducer does not show a blister on its front face or does not feel unusually when it is safe for use); to immediately discontinue use and contact their local Siemens representative to get issue resolved, if the transducers developed a hot spot that exhibits a visible blister on the patient contact surface and feels hot to the touch during operation, and to pass this notice on to all those within their organization who need to be aware. If you have any questions, please contact (650) 969-9112 or (800) 422-8766.
Quantity in Commerce 196 total units, transducers and SC2000
Distribution Worldwide Distribution: USA and countries including: Australia, Belgium, Brazil, China, Czech Republic, Finland, France, Germany, India, Ireland, Italy, Japan, Kenya, Malaysia, Netherlands, Norway, Portugal, South Korea, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
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