Recall Z-0283-2024— Philips Ultrasound, Inc.
Class II · Completed
Class II FDA medical device recall by Philips Ultrasound, Inc., initiated 2023-10-09. It names one FDA 510(k) clearance: K231190. Product: Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 795231), EPIQ Elite (model # 795234). Reason: Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image..
- Recalling firm
- Philips Ultrasound, Inc.
- Classification
- Class II
- Status
- Completed
- Initiated
- 2023-10-09
- Firm location
- Bothell, WA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 795231), EPIQ Elite (model # 795234)
Reason for recall
Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image.
Data sourced from openFDA. This site is unofficial and independent of the FDA.