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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Diagnostic Ultrasound System

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 Class 2 Recall
Philips Diagnostic Ultrasound System
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Date Posted December 31, 2008
Recall Status1 Open
Recall Number Z-0522-2009
Recall Event ID 49065
Premarket Notification
510(K) Number
K031552 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product Philips Diagnostic Ultrasound System, Model HD3. Product labeled HD3 Ultrasound System, Distributed by Philips Ultrasound, 22100 Bothell-Everett Highway, Bothell, WA 98021. Pulse Doppler Imaging Systems used for diagnostic ultrasound imaging or fluid analysis of human body.
Code Information Software Level 2.0 and prior are affected. The software level of the HD3 system may be found on the splash screen during system boot up. Serial numbers: 61202300000000, A5202300000039, A56202300000001, A56202300000003, A56202300000004, A56202300000005, A56202300000006, A56202300000007, A56202300000009, A56202300000010, A56202300000011, A56202300000012, A56202300000013, A56202300000014, A56202300000015, A56202300000016, A56202300000017, A56202300000018, A56202300000019, A56202300000020, A56202300000021, A56202300000022, A56202300000023, A56202300000024, A56202300000025, A56202300000026, A56202300000027, A56202300000028, A56202300000029, A56202300000030, A56202300000031, A56202300000032, A56202300000033, A56202300000034, A56202300000035, A56202300000036, A56202300000037, A56202300000038, A56202300000040, A56202300000041, A56202300000042, A56202300000043, A56202300000044, A56202300000045, A56202300000046, A56202300000047, A56202300000048, A56202300000049, A56202300000050, A56202300000051, A56202300000052, A56202300000053, A56202300000054, A56202300000055, A56202300000056, A56202300000057, A56202300000058, A56202300000059, 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Recalling Firm/
Manufacturer
Philips Medical Systems
3000 Minuteman Road
Andover, Massachusetts 01810
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Beth Brouillette
978-659-4884
Manufacturer Reason
for Recall
The system has a software defect that affects the display of Estimated Fetal Weight (EFW) Growth Percentile result values.
FDA Determined
Cause 2
DESIGN: Software Design (Manufacturing Process)
Action On 8/12/08, the firm sent an Urgent - Medical Device Correction letter, dated July 2008, to all affected customers via UPS. The letter describes the reason for the recall, informs them that Philips Ultrasound is correcting the error, states that the software is under development, will be available in September 2008 and will contact the customer to upgrade their system. "In the interim, Philips recommends that you only use the Hadlock or Osaka growth tables to perform your EFW Growth Percentile calculations. You should make the appropriate selections in the Analysis Setup menu on your system.".
Quantity in Commerce 4279 units
Distribution Worldwide Distribution --- including USA and countries of Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bosnia, Brazil, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Dominican Rep, Ecuador, Egypt, El Salvador, France, Germany, Greece, Guam, Guatemala, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Jordan, Kuwait, Malaysia, Martinique, Mexico, Moldova, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syrian Arab Rep, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Utd Arab Emirr., Venezuela, Viet Nam, Canada, Afghanistan, Albania, Argentina, Australia, Austria, Belgium, Bolivia, Bosnia, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, El Salvador, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Italy, Japan, Korea Rep, Latvia, Lebanon, Lithuania, Malaysia, Mauritius, Mexico, Moldova, Morocco, Namibia, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Paraguay, Peru, Poland, Portugal, Puerto Rico, Romania, Serbia, Singapore, SLOVAKIA, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, Ukraine, United Kingdom, Uzbekistan, Venezuela, and Virgin Isl (Br).
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 = MEDISON AMERICA, INC.
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