Recall Z-2483-2021 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Philips Ultrasound Inc
EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205 EPIQ 5G - 795204 EPIQ 7 - 795117 EPIQ 7C - 795201 EPIQ 7G - 795200 EPIQ CVxi -795232 EPIQ CVx - 795231
| Date | Aug 6, 2021 |
| Status | Completed |
| Reason | Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam. |
| Root cause | Software design |
| Action | On 08/06/2021, the firm sent via certified mail an "URGENT Medical Device Correction" Notification Letter to customer informing them that due to a software defect, when reviewing or adjusting xPlane exam results, there is a potential for the ultrasound systems to become unresponsive (Lock-up) preventing users from continuing clinical use. The ultrasound system provides an error notification including method to restart and bring system back to normal use. The Recalling Firm has received a report of an ultrasound system locking up multiple times during an open cardiac procedure while using a Tr |
| Quantity | Total = 10,583 systems (EPIQ and Afiniti) |
| Distribution | Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countrie |
| 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 |