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U.S. Department of Health and Human Services

Class 3 Device Recall Voluson Pro/Expert

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  Class 3 Device Recall Voluson Pro/Expert see related information
Date Initiated by Firm February 24, 2006
Date Posted June 27, 2006
Recall Status1 Terminated 3 on January 06, 2007
Recall Number Z-1172-06
Recall Event ID 35066
510(K)Number K041688  
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product Voluson 730 Expert, Voluson 730 Pro, Voluson 730 ProV with software versions 4.0.0, 4.0.1, 4.0.2, 4.0.3, 4.0.4, 4.0.5, 5.00, 5.0.1. The device is a general-purpose diagnostic ultrasound system.
Code Information Software versions 4.0.0, 4.0.1, 4.0.2, 4.0.3, 4.0.4, 4.0.5, 5.00, 5.0.1. Serial number ranges A06251 thru A09914, A12012 thru A31198 and A35001 thru 35097 may include devices that are not subject to the correction.  Serial number ranges A10000 thru A11087 and A31201 thru A33742 only include devices subject to the correction
Recalling Firm/
Manufacturer		 General Electric Med. Sys. Ultrasound
4855 W Electric Ave
West Milwaukee WI 53219-1628
Manufacturer Reason
for Recall		 In the cardiac measurement section of the device the calculation of the 'PG Mean' (mean pressure gradient) leads to an erroneous result. It is recommended that customers with affected units do not use the measurement in question 'PG Mean' for any diagnostic or therapeutic decision, and 'PG Mean' values should not be included in any patient documentation.
FDA Determined
Cause 2		 Other
Action An Urgent Medical Device Correction letter to customers 04/17/2006, states the product affected, provides a recommendation for affected units continued use until a software update is provided to the facility by a GE Healthcare Representative. Customers are recommended to not use the measurement in question 'PG Mean' for any diagnostic or therapeutic decision, and 'PG mean' values should not be included in any patient documentation.
Quantity in Commerce 3,936 (969 US and 2,967 OUS)
Distribution Nationwide, Puerto Rico and OUS to include: Algeria, Argentina, Austria, Belgium, Bosnia and Herzegovina, Brazil, Republic of Bulgaria, Byelorussian SSR, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, DVU Australia, Ecuador, Egypt, Finland, France, Federal Republic of Germany, Greece, Hong Kong, Republic of Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Kuwait, Republic of Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Kingdom of Saudi Arabia, Singapore, Republic of Slovenia, Spain, Sudan, Sweden, Switzerland, Taiwan, United Republic of Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Venezuela, Vietnam, Yemen, Yugoslavia
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 = GENERAL ELECTRIC CO.
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