Konica Minolta Sonimage HS1 Ultrasound Kit AC Adapter Recall
Konica Minolta is recalling 85 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 (3) 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 85 units of the Sonimage HS1 Ultrasound Kit AC adapter, Product Number A8WA. The recall involves specific serial numbers listed in the agency's official notice.
The recall is being conducted because there is a risk of circuit board breakage within the main housing of the AC Adapter unit. As a direct result of this breakage, smoke may be emitted from the adapter.
The affected units were distributed in 34 U.S. states and the District of Columbia, as well as in Canada and Brazil. Users should stop using the affected AC adapters immediately and contact Konica Minolta Medical Imaging USA, Inc. for instructions on replacement or repair.
The recalled product
- Product
- Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, UDI: 04560141944534
- Manufacturer
- Konica Minolta Medical Imaging USA, Inc.
- Affected units
- 85
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 →Related recalls
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