Recall Z-0947-2021 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Philips Ultrasound Inc
Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi - Product Usage: 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.
| Date | Dec 24, 2020 |
| Status | Terminated |
| Reason | Control panel arm assembly could have missing or loose screws where undue force, pressure or weight is applied, the control panel mechanism can fail and break off. |
| Root cause | Process control |
| Action | On 12/24/2020, the firm sent an "URGENT Medical Device Correction" Letter via certified mail to customers informing them that it has been detected 1 to 4 missing or loose screws on the base of the control panel arm and there is a potential for the arm to break and collapse if pressure is applied while adjusting or moving the control panel. Customers are instructed: WHEN USING THE SYSTEM: - Do not apply downward force on the Ultrasound system cart or control panel when the control arm is locked or in the lowest position. This includes leaning/bracing yourself with the system, such as when reac |
| Quantity | 12,080 systems |
| Distribution | Worldwide distribution - US Nationwide, Puerto Rico, and Virgin Islands. O.U.S.: AE - United Arab Emirates AL - Albania AM - Armenia AR - Argentina AT - Austria AU - Australia AZ - Azerbaijan BA - Bosnia BD - Bangladesh BE - Belgium BG - Bulgaria BH - Bahrain BN - Brunei BO - Bolivia BR - Brazil BY |
| 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 |