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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
see related information
Date Posted December 31, 2008
Recall Status1 Open
Recall Number Z-0523-2009
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 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, A25000108, A25000110, A25000112, A25000113, A25000114, A25000115, A25000116, A25000117, A25000118, A25000119, A25000120, A25000121, A25000122, A25000123, A25000124, A25000125, A25000126, A25000127, A25000128, A25000129, A25000130, A25000131, A25000132, A25000133, A25000134, A25000135, A25000137, A25000138, A25000139, A25000140, A25000142, A25000143, A25000144, A25000145, A25000146, A25000147, A25000148, A25000149, A25000150, A25001682, A26000151, A26000152, A26000153, A26000153, A26000154, A26000155, A26000156, A26000157, A26000158, A26000159, A26000160, A26000162, A26000163, A26000164, A26000165, A26000166, A26000168, A26000169, A26000170, A26000171, A26000172, A26000173, A26000174, A26000175, A26000176, A26000177, A26000178, A26000179, A26000180, A26001694, A26001696, A26001698, A26001700, A27000181, A27000182, A27000183, A27000184, A27000185, A27000186, A27000187, A27000188, A27000189, A27000190, A27000191, A27000192, A27000194, A27000195, A27000196, A27000197, A27000198, A27000199, 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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 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 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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