FDAApril 24, 2017device
Diagnostics Ultrasound System Ultrasounds System Sonimage HS1
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.
What to do
FDA enforcement status: Terminated
Brands named
konica minoltakonica
UPCs
04560141940031045601419445340456014194546304560141946385
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics Product number: ADFR and ADJC2021-12-03
- FDABucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17; Board Name; Board Version, Firmware Version Advanced Universal U-Arm 4000 System. The Positioner consists of the following associated subassemblies: Vertical Column, Swivel Arm with variable height, X-ray Tube, Automatic Exposure ...2018-11-08
- FDACS-7, Model No. A4C12018-05-09
- FDAImagePilot, Model No. D9MA2018-05-09
- FDASonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2. AAEU, UDI: 04560141946385; 3. A9RR, UDI: 045601419454702017-12-04
- FDASonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 045601419415882017-12-04
- FDASonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 045601419400312017-12-04
- FDASonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, UDI: 045601419445342017-12-04
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