Recall Z-1007-2026— Philips Ultrasound, LLC

Name: FDA recall Z-1007-2026
Creator: U.S. Food and Drug Administration
Published: 2022-07-14

Class II · Completed

Class II FDA medical device recall by Philips Ultrasound, LLC, initiated 2022-07-14. It names one FDA 510(k) clearance: K231190. Product: Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122. Reason: Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer..

Recalling firm: Philips Ultrasound, LLC
Classification: Class II
Status: Completed
Initiated: 2022-07-14
Firm location: Bothell, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K231190 — EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC·cleared 2023-05-12

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

Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122

Reason for recall

Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.

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