The Recall Desk
HighFDA (Devices)·Z-1214-2018·Announced 2018-04-04

Konica Minolta Recalls Sonimage HS1 Ultrasound Kit AC Adapters

Konica Minolta is recalling 30 Sonimage HS1 Ultrasound Kit AC adapters due to a risk of circuit board breakage and smoke emission.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk of smoke emission from a medical device, which poses a potential fire or burn hazard. Per the rubric, this is classified as High because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Konica Minolta Medical Imaging USA, Inc. is recalling 30 units of the Sonimage HS1 Ultrasound Kit AC adapter. The affected units include product numbers A9RP, AAEU, and A9RR, with specific serial numbers listed in the official recall notice.

The recall is being conducted because there is a risk of circuit board breakage within the main housing of the AC adapter unit. This defect may result in smoke being emitted directly from the adapter. The devices were distributed in 34 U.S. states and the District of Columbia, as well as in Canada and Brazil.

Consumers and healthcare facilities should stop using the affected AC adapters immediately. Users should contact Konica Minolta Medical Imaging USA, Inc. for instructions on how to return the product or obtain a replacement.

The recalled product

Product
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2. AAEU, UDI: 04560141946385; 3. A9RR, UDI: 04560141945470
Affected units
30

Distribution

Part of a larger recall action

This product is one of 4 recalled by Konica Minolta Medical Imaging USA, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Konica Minolta Medical Imaging USA, Inc.

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