• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ACUSON SC 2000 ultrasound system

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall ACUSON SC 2000 ultrasound system see related information
Date Posted December 28, 2010
Recall Status1 Terminated 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
650-694-5993
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
-
-