Brand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 Catalog 1125, Burn ...
FDA Device Recall #Z-2295-2019 — Class II — March 16, 2015
Recall Summary
| Recall Number | Z-2295-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 16, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Arcos, Inc |
| Location | Missouri City, TX |
| Product Type | Devices |
| Quantity | 28 |
Product Description
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
Reason for Recall
Battery packs may heat up abnormally and ignite in rare instance.
Distribution Pattern
US: AZ, LA, OR, MD, TX, and WA. OUS: No products were distributed outside the US.
Lot / 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*
Frequently Asked Questions
Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.