Recall Z-2483-2021— Philips Ultrasound Inc

Name: FDA recall Z-2483-2021
Creator: U.S. Food and Drug Administration
Published: 2021-08-06

Class II · Completed

Class II FDA medical device recall by Philips Ultrasound Inc, initiated 2021-08-06. It names one FDA 510(k) clearance: K182857. Product: 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. Reason: Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam..

Recalling firm: Philips Ultrasound Inc
Classification: Class II
Status: Completed
Initiated: 2021-08-06
Firm location: Bothell, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K182857 — EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.·cleared 2018-11-09

K-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

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

Reason for recall

Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.

Data sourced from openFDA. This site is unofficial and independent of the FDA.