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

Class 2 Device Recall 4Z1c matrix array transducer

  • 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 4Z1c matrix array transducer see related information
Date Posted December 28, 2010
Recall Status1 Terminated on October 04, 2011
Recall Number Z-0826-2011
Recall Event ID 57289
510(K)Number K072365 
Product Classification System, imaging, pulsed doppler, ultlrasonic - Product Code IYN
Product 4Z1c matrix array transducer which is used with ACUSON SC2000 ultrasound system.
Siemens Medical Solutions USA, Inc.
Business Unit Ultrasound
1230 Shorebird Way
Mountain View, CA 94043

Intended use: 4Z1 transducer is a special purpose ultrasound transducer designed to help clinicians perform adult echocardiography and pre-operative and intra-operative surgical assessments. Secondary applications include: pediatric, echocardiography, primarily benefiting older and larger pediatric populations, general abdominal and Pinta-operative pediatric abdominal imaging and peripheral vessel imaging.
Code Information Material number: 10433816:
Serial numbers:
82638701
82741703
84254503
84355608
84455108
84754522
84857919
91861815
84858401
84655617
91654526
83044913
90261810
90864208
01288401
61101009
61601024
81631208
83146817
83251905
83751103
83752419
84455113
84557302
84753934
84857907
85056212
91503602
93771403
94982205
83650009
90656713
95183003
84456707
84153940
84857908
84857918
84953903
92068501
92256206
82540305
84053927
83853304
84656203
94065109

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 units both Transducer and ACUSon 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
-
-