Class 2 Device Recall Philips Diagnostic Ultrasound System

• Date Initiated by Firm: August 12, 2008
• Date Posted: December 31, 2008
• Recall Status: Terminated on July 14, 2011
• Recall Number: Z-0523-2009
• Recall Event ID: 49065
• 510(K)Number: K031552
• Product Classification: Ultrasonic Pulsed Doppler Imaging System - Product Code IYN
• Product: Philips Diagnostic Ultrasound System, Model HDI4000. Product labeled HDI4000 Ultrasound System, Distributed by Philips Ultrasound, 22100 Bothell-Everett Highway, Bothell, WA 98021. Product also marketed as Philips 4000 New Standard, Philips 4000 System and Multibeam System. According to the firm, these units have the same user manual as the HDI4000 system. The different names are used internally as a description for the different configurations of model HDI 4000. Over the product lifecycle, the product configuration changed as follows: MULTIBEAM SYSTEM : This was the original HDI 4000 system branded with the former company name 'ATL' and labeled, "Distributed by ATL Ultrasound Bothell, WA. USA 98041"; PHILIPS 4000 SYSTEM :This configuration changed the legacy 'ATL' brand / colors to the 'Philips' brand / colors; PHILIPS 4000 NEW STANDARD: This Philips brand configuration eliminated hardware that supported the 'CV'. The CV option was initially standard, but later became optional depending on customer preference. The product ID label is the same for both PHILIPS 4000 SYSTEM and PHILIPS 4000 NEW STANDARD. ; ; Pulse Doppler Imaging Systems used for diagnostic ultrasound imaging or fluid analysis of human body.
• Code Information: All HDI4000 Systems in distribution are affected. Serial Part: A1C000003, A21000009, A21000010, A21000011, A21000012, A21000013, A21000015, A21000016, A21000017, A21000018, A21000019, A21000020, A21000021, A21000022, A21000023, A21000024, A21000026, A21000027, A21000028, A21000029, A21000030, A21000032, A21000033, A21000034, A21000035, A21000036, A21000037, A21000039, A23000040, A23000041, A23000042, A23000043, A23000044, A23000045, A23000046, A23000047, A23000048, A23000050, A24000051, A24000052, A24000054, A24000055, A24000056, A24000057, A24000058, A24000060, A24000061, A24000063, A24000064, A24000065, A24000066, A24000067, A24000068, A24000070, A24000071, A24000072, A24000073, A24000074, A24000075, A24000076, A24000077, A24000078, A24000079, A24000080, A24000081, A24000082, A24000083, A24000084, A24000085, A24000086, A24000087, A24000088, A24000089, A24000091, A24000092, A24000093, A24000094, A24000095, A24000096, A24000097, A24000098, A24000100, A24000101, A24000102, A24000103, A24000104, A24000105, A25000106, A25000107, 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• Recalling Firm/ Manufacturer: Philips Medical Systems; 3000 Minuteman Road; Andover MA 01810
• 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: Software design
• 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: 1902 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 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 = MEDISON AMERICA, INC.