Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70. Product Usage: The intended use of the EPIQ, EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Or Jan (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal. When integrated with Philips EchoNavigator, the systems can assist the interventionist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance.
This recall has been terminated (originally issued August 6, 2019).
- Company
- Philips Ultrasound, Inc.
- Recall Initiated
- April 29, 2019
- Posted
- August 6, 2019
- Terminated
- August 4, 2022
- Recall Number
- Z-2199-2019
- Quantity
- 3,146 devices
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
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 the device.
Distribution
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.
Lot / Code Info
All models containing software version 4.0.
Root Cause
Software design
Action Taken
The recalling firm issued letters dated 4/26/2019 on 4/29/2019 via certified mail with delivery confirmation. The letter identified the affected product, problem and actions to be taken.