Z-2199-2019 Class II Terminated
FDA device recall Z-2199-2019 was initiated by Philips Ultrasound Inc on April 29, 2019 and is designated Class II. Reason for recall: There is a potential that the image of one patient could get unexpectedly moved into another patient's folder when the user is using the Edit functionality on the Patient Data Entry (PDE) screen of th… The recall status is terminated (terminated August 4, 2022). Affected quantity: 3,146 devices.
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2019
- Initiation Date
- April 29, 2019
- Termination Date
- August 4, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,146 devices
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - US Nationwide, including Puerto Rico. There was also military/government distribution. Foreign distribution was made to Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Latvia, Luxembourg, Malaysia, Mayotte, Mexico, Monaco, Morocco, Netherlands, New Zealand, Nicaragua, Norway, Oman, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United Kingdom Virgin Islands, Uruguay, and Viet Nam.