Z-2295-2019Class II

Brand Name Burn Navigator Model Numbers: Catalog 1120, Burn Navigator H2 Catalog 1125, Burn Navigator H2...

Name: Z-2295-2019 Brand Name Burn Navigator Model Numbers: Catalog 1120, Burn Navigator H2 Catalog 1125, Burn Navigator H2...
Creator: Arcos, Inc
Published: 2015-03-16
License: https://open.fda.gov/license/

Arcos, Inc / initiated 2015-03-16 / Terminated / root cause: design

FDA source

Arcos, Inc began a recall of Brand Name Burn Navigator Model Numbers: Catalog 1120, Burn Navigator H2 Catalog 1125, Burn Navigator H2 Transport Package Burn Navigator User Manual... on 2015-03-16. FDA classified it as Class II and gives the reason as "Battery packs may heat up abnormally and ignite in rare instance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2295-2019
Classification: Class II
Status: Terminated
Initiated: 2015-03-16
Posted: 2019-08-21
Terminated: 2022-02-09
Recalling firm: Arcos, Inc
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
Product code: PDT Burn Resuscitation Decision Support Software
Reason for recall: Battery packs may heat up abnormally and ignite in rare instance.
Root cause tag: design
FDA root cause: Component design/selection
Action: On March 20, 2015, the firm sent an email with a Battery Replacement Program Attachment. The Attachment informed customers that it main hardware supplier had notified them that some batteries used with tablet computers have in rare instances, overheated and caught fire. The Attachment instructed customers to check the batteries in the computer tablets to determine if they matched the serial numbers for the batteries being replaced. Customer were instructed to: 1) Remove Battery Pack - shut down their PC and remove the battery pack (noting that there are two battery slots, one on each the left and right side of the Tablet Computer. 2) Review Battery Pack Model Number and Manufacturing Lot Number - by reviewing battery pack nameplate. The following Battery Pack Model Numbers and Manufacturing Lot Numbers must be replaced: Battery Pack Model Numbers: Manufacturing Lot Number CF-VZSU53AW Beginning with B, C1, C2, C3, C4, C5, CF-VZSU53AR C6, C7, C8, C93, C94, C96, C9C, C9J, CF-VZSU53AQ C9K If the customer has the affected batteries, they are to contact the firm whether or not the batteries match the criteria so that the firm will know the status of the customer's batteries. If batteries match the criteria, the firm will replace them for free. Contact Information: Toll Free Phone Number: 877-542-8025 In addition Tablet Computers can continue to be operated with wall power or with batteries not affected by the recall.
Quantity in commerce: 28
Distribution: US: AZ, LA, OR, MD, TX, and WA. OUS: No products were distributed outside the US.
Product codes and lots: The Battery Packs are referred to as component number CMP-1523 in the Burn Navigator User's Manual). The Model/Catalog Numbers 1120 and 1125 are associated with the Burn Navigator H2. Model 1120 (Qty 20) Model 1125 (Qty 8) 2EKSA25422 3HKSB54129 2GKSA30512 3HKSB54132 2GKSA30513 3HKSB54136 2GKSA31162 3HKSB54143 2JKSA37073 4BKSA60753 2JKSA37077 4BKSA60758 2JKSA37465 4BKSA60776 2JKSA37887 4BKSA60786 2LKSA43100 2LKSA43540 2LKSA43541 3FKSB51215 3FKSB51217 3HKSB54006 3HKSB54008 3HKSB54115 3HKSB54140 3HKSB54142 4CKSA61744 4CKSA61752 Battery Models and Lot Numbers: Model: CF-VZSU53AW CF-VZSU53AR CF-VZSU53AQ 4 digit alphanumeric Panasonic Lot Numbers beginning with: B**** C1** C2** C3** C4** C5** C6** C7** C8** C93* C94* C96* C9C* C9J* C9K*

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2295-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2295-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-21

Product code PDT

K121659Class IIBurn Resuscitation Decision Support System (Brdss)Arcos, Inc. / cleared 2013-04-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)