Z-0523-2009

Philips Diagnostic Ultrasound System, Model HDI4000. Product labeled HDI4000 Ultrasound System, Distributed...

Name: Z-0523-2009 Philips Diagnostic Ultrasound System, Model HDI4000. Product labeled HDI4000 Ultrasound System, Distributed...
Creator: Philips Medical Systems
Published: 2008-08-12
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-08-12 / Terminated / root cause: software

FDA source

Philips Medical Systems began a recall of Philips Diagnostic Ultrasound System, Model HDI4000. Product labeled HDI4000 Ultrasound System, Distributed by Philips Ultrasound, 22100 Bothell-Everett... on 2008-08-12. The reason FDA records is "The system has a software defect that affects the display of Estimated Fetal Weight (EFW) Growth Percentile result values". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0523-2009
Status: Terminated
Initiated: 2008-08-12
Posted: 2008-12-31
Terminated: 2011-07-14
Recalling firm: Philips North America LLC
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.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: The system has a software defect that affects the display of Estimated Fetal Weight (EFW) Growth Percentile result values.
Root cause tag: software
FDA root 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).
Product codes and lots: 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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Product code IYN

K031552Class IIMycolor 202 Diagnostic Ultrasound System and TransducersMedison America, Inc. / cleared 2003-05-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)