Recall Z-0523-2009 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Philips Medical Systems
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 interna
| Date | Dec 31, 2008 (initiated Aug 12, 2008) |
| Status | Terminated |
| Reason | The system has a software defect that affects the display of Estimated Fetal Weight (EFW) Growth Percentile result values. |
| 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 | 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, In |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031552 | MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS Medison America, Inc., May 30, 2003 |