Class 2 Device Recall Burn Navigator

• Date Initiated by Firm: March 16, 2015
• Create Date: August 21, 2019
• Recall Status: Terminated on February 09, 2022
• Recall Number: Z-2295-2019
• Recall Event ID: 81594
• 510(K)Number: K121659
• Product Classification: Burn resuscitation decision support software - Product Code PDT
• 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
• Code Information: 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*
• Recalling Firm/ Manufacturer: Arcos, Inc; 5819 Highway 6 Ste 150; Missouri City TX 77459-4061
• For Additional Information Contact: Christopher Meador; 713-397-3030
• Manufacturer Reason for Recall: Battery packs may heat up abnormally and ignite in rare instance.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = PDT and Original Applicant = ARCOS, INC.