Recall Z-1213-2018— Konica Minolta Medical Imaging USA, Inc.

Name: FDA recall Z-1213-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-04

Class II · Terminated

Class II FDA medical device recall by Konica Minolta Medical Imaging USA, Inc., initiated 2017-12-04, terminated 2019-10-28. It names one FDA 510(k) clearance: K152577. Product: Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, UDI: 04560141944534. Reason: There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted from the AC Adapter as a direct result..

Recalling firm: Konica Minolta Medical Imaging USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-12-04
Terminated: 2019-10-28
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K152577 — ULTRASOUND SYSTEM SONIMAGE HS 1Konica Minolta, Inc.·cleared 2015-10-08

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

Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, UDI: 04560141944534

Reason for recall

There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted from the AC Adapter as a direct result.

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