Recall Z-2769-2017— Konica Minolta, Inc.
Class II · Terminated
Class II FDA medical device recall by Konica Minolta, Inc., initiated 2017-04-24, terminated 2018-01-24. It names 3 FDA 510(k) clearances: K162065, K152577, K142197. Product: Diagnostics Ultrasound System Ultrasounds System Sonimage HS1. Reason: The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate..
- Recalling firm
- Konica Minolta, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-04-24
- Terminated
- 2018-01-24
- Firm location
- Wayne, NJ, United States
510(k) clearances named in this recall
3 on FDA's record- K162065 — Ultrasound System SONIMAGE HS1
- K152577 — ULTRASOUND SYSTEM SONIMAGE HS 1
- K142197 — ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2
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
Diagnostics Ultrasound System Ultrasounds System Sonimage HS1
Reason for recall
The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.
Data sourced from openFDA. This site is unofficial and independent of the FDA.