Medical device recalls Moderate risk

ImagePilot recalled over fire hazard

Recall date
May 9, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Konica Minolta Medical Imaging USA, Inc. recalls ImagePilot, Model No. D9MA
Recall number
Z-2282-2018
FDA classification
Class II
Brand / firm
Konica Minolta Medical Imaging USA, Inc.
Sold / distributed
Nationwide distribution. Foreign distribution to Argentina, Brazil, Canada, Chile, Colombia, Ecuador, Japan, Mexico, Netherlands, and Peru.

Why it was recalled

Panasonic has issued a Mandatory Product Safety Notice, indicating a possibility of battery ignition (fire) in CF-C2 "Toughbook" laptops. Since Konica Minolta uses this laptop in some of its product configurations, it notified its customers to utilize a BIOS Utility for the laptops to minimize the risk of an incident while Panasonic develops a final solution.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ImagePilot, Model No. D9MA

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