| |
Class 2 Device Recall Philips Diagnostic Ultrasound System |
 |
| Date Initiated by Firm |
August 12, 2008 |
| Date Posted |
December 31, 2008 |
| Recall Status1 |
Terminated 3 on July 14, 2011 |
| Recall Number |
Z-0522-2009 |
| Recall Event ID |
49065 |
| 510(K)Number |
K031552
|
| Product Classification |
Ultrasonic Pulsed Doppler Imaging System - Product Code IYN
|
| Product |
Philips Diagnostic Ultrasound System, Model HD3. Product labeled HD3 Ultrasound System, Distributed by Philips Ultrasound, 22100 Bothell-Everett Highway, Bothell, WA 98021.
Pulse Doppler Imaging Systems used for diagnostic ultrasound imaging or fluid analysis of human body.
|
| Code Information |
Software Level 2.0 and prior are affected. The software level of the HD3 system may be found on the splash screen during system boot up. 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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 2 |
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 |
4279 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
|
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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.
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