Recall Z-2199-2019 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Philips Ultrasound Inc
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 t
| Date | Aug 6, 2019 (initiated Apr 29, 2019) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 3,146 devices |
| 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, Denm |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182857 | EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Philips Ultrasound, Inc., Nov 9, 2018 |