The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1212-2018·Announced 2018-04-04

Konica Minolta Sonimage HS1 Ultrasound AC Adapter Recall for Fire Risk

Konica Minolta is recalling 88 Sonimage HS1 Ultrasound Kit AC adapters due to a risk of circuit board breakage that may cause smoke emission.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 hazard. No injuries or illnesses have been reported, placing this in the 'High' category for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Konica Minolta Medical Imaging USA, Inc. is recalling 88 units of the Sonimage HS1 Ultrasound Kit AC adapter (Product Number: A7AP, UDI: 04560141940031). 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 emission 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 units were also distributed in Canada and Brazil. Specific serial numbers are listed in the official recall notice, all prefixed with "A7AP-".

Consumers should check their AC adapter serial number against the list provided by the manufacturer or the FDA. If the unit is affected, users should stop using the adapter and contact Konica Minolta Medical Imaging USA, Inc. for instructions on repair or replacement.

The recalled product

Product
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031
Manufacturer
Konica Minolta Medical Imaging USA, Inc.
Category
Medical Device — Ultrasound Equipment
Hazard
Affected units
88

Distribution

Distributed in 35 states:

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 →

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