Konica Minolta Sonimage HS1 Ultrasound Kit AC Adapter Recall
Konica Minolta is recalling 17 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 is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Konica Minolta Medical Imaging USA, Inc. is recalling 17 units of the Sonimage HS1 Ultrasound Kit AC adapter (Product Number: A8AR, UDI: 04560141941588). The recall is due to a risk of circuit board breakage within the main housing of the AC adapter unit, which may result in smoke being emitted from the device.
The affected units were distributed in the following U.S. states: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, WA, WI, and the District of Columbia. The products were also distributed in Canada and Brazil. The specific serial numbers for the recalled units are: 00068, 00031, 00062, 00066, 00063, 00047, 00065, 00032, 00064, 00028, 00069, 00060, 00027, 00067, 00061, 00001, and 00002 (each with the prefix "A8AR-").
Consumers and healthcare facilities should check their inventory for these specific serial numbers. If a unit matches the recalled list, it should be removed from service immediately to prevent potential smoke emission or equipment damage.
The recalled product
- Product
- Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588
- Manufacturer
- Konica Minolta Medical Imaging USA, Inc.
- Affected units
- 17
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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