The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2295-2019·Announced 2019-08-28

Arcos Burn Navigator H2 Recalled for Battery Fire Risk

Arcos, Inc. is recalling 28 Burn Navigator H2 units because their battery packs may heat up abnormally and ignite in rare instances.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a fire hazard (ignition) associated with a medical device, which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk product defects, warranting a Severe classification.

Plain-English summary

Arcos, Inc. is recalling 28 units of the Burn Navigator H2 medical device, including models 1120 and 1125. The recall involves specific Panasonic battery packs (Model CF-H2, Part Number CMP-1523) that may heat up abnormally and ignite in rare instances.

The affected units were distributed in the United States to Arizona, Louisiana, Oregon, Maryland, Texas, and Washington. No products were distributed outside the US. The recall covers specific serial numbers and battery lot numbers detailed in the agency's structured data.

Consumers who possess these specific Burn Navigator H2 units should stop using them immediately and contact Arcos, Inc. for instructions on how to return the product or obtain a replacement.

The recalled product

Product
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
Manufacturer
Arcos, Inc
Category
Medical Device — Burn Care
Hazard
Affected units
28

Distribution

Distributed in 6 states:

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