Therefore, we encourage you to read this Privacy Notice carefully. We also believe it is important to inform you about how we will use your personal information, and to give you choices about how this information will be used. Philips believes strongly in protecting the privacy of the personal information you share with us. This is a notice not a contract or agreement.
PHILIPS QLAB REGISTRATION
or is subsidiaries (“Philips”) in connection with the registration and use of the Ultrasound software applications.
PHILIPS QLAB CODE
Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.ĥ10(K)s with Product Code = LLZ and Original Applicant = SONOSCAPE MEDICAL CORP.This Privacy Notice applies to all personal information of customers collected or used by Koninklijke Philips, N.V. 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. Customers are directed to call local Philips representative or Philips Customer Service at 1-86.ĥ9 units total (12 units in the US and 47 units outside the US)ĭistributed in the states of CA, IA, KY, MD, NY, PA, UT, VA, WA and WI.Īlso distributed in Australia, Belgium, Canada, India, Italy, Japan, South Korea, Netherlands, New Zealand, Spain, Sweden, and Switzerland.ġ A record in this database is created when a firm initiates a correction or removal action. Philips Medical Systems will also have Customer Reply Cards returned for tracking purposes. Philips representatives will distribute the letter internationally.įollow-up letters to wholesale customers will be provided and wholesalers are requested to forward copies of recall letters and response forms to their customers. Philips Medical Systems notified customers of the voluntary recall by sending a certified URGENT-Medical Device Correction letter, dated 2014 JUL 09, to all US and Canadian consignees.
The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
System, image processing, radiological - Product Code LLZ Class 2 Device Recall Philips Ultrasound QLAB
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