The Recall Desk

FDA (Devices) recall action 79455

Konica Minolta Medical Imaging USA, Inc. recalled 4 products on 2018-04-04

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2018-04-04
Critical
0
Units
220

Why these products were recalled

There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted from the AC Adapter as a direct result.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • HighFDA (Devices)··2018-04-04

    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.

    Product
    Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588
    Category
    Distribution
    35 states
  • HighFDA (Devices)··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.

    Product
    Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031
    Category
    Distribution
    35 states
  • HighFDA (Devices)··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.

    Product
    Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2. AAEU, UDI: 04560141946385; 3. A9RR, UDI: 04560141945470
    Category
    Distribution
    35 states
  • HighFDA (Devices)··2018-04-04

    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.

    Product
    Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, UDI: 04560141944534
    Category
    Distribution
    35 states