Recall Z-2484-2021— Philips Ultrasound Inc

Name: FDA recall Z-2484-2021
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: Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affiniti 30 795218 Affiniti 50 795208 Affiniti 50 795118 Affiniti 70 795210 Affiniti 70 795119. 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

Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affiniti 30 795218 Affiniti 50 795208 Affiniti 50 795118 Affiniti 70 795210 Affiniti 70 795119

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.