Medical device recalls Moderate risk

Arcos, Inc recalls Brand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 Catalog 1125, Burn Navigator¿ H2 Transport P…

Recall date
March 16, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2295-2019
FDA classification
Class II
Brand / firm
Arcos, Inc
Sold / distributed
US: AZ, LA, OR, MD, TX, and WA. OUS: No products were distributed outside the US.

Why it was recalled

Battery packs may heat up abnormally and ignite in rare instance.

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

What was recalled

Brand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 Catalog 1125, Burn Navigator¿ H2 Transport Package Burn Navigator User Manual Manual-1120 Burn Navigator User's Manual, Rev. F Battery: Panasonic Model CF-H2 Part Number CMP-1523

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