Company:Philips Ultrasound, Inc
Date of Enforcement Report 3/4/2009
Class:ll
PRODUCT
a) Philips Diagnostic Ultrasound System, Model HD3. Product labeled HD3 Ultrasound System. Pulse Doppler Imaging Systems used for diagnostic ultrasound imaging or fluid analysis of human body. Recall # Z-0522-2009;
b) Philips Diagnostic Ultrasound System, Model HDI4000. Product labeled HDI4000 Ultrasound System. 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’; 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. Recall # Z-0523-2009
REASON
The system has a software defect that affects the display of Estimated Fetal Weight (EFW) Growth Percentile result values.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems, Andover MA , by letter dated July 2008.
Manufacturer: Philips Ultrasound, Inc., Bothell , WA . Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
6,181 Units
DISTRIBUTION
Nationwide and Internationally
