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HELIOS System

TACTICAL MEDICAL SOLUTIONS, LLC · Model A · UDI-DI 00818630010463

IMD

510(k) clearances

4,404

Adverse events (11 deaths)

Recalls

381

Facilities

Description

Casualty hypothermia prevention and management system with active warming for use in pre-hospital environments. Adjustable two-piece blanket casualty wrap system design for quick access to the casualty with an active warming heat pack. Blanket anchors can be secured to most litters to reduce exposure from rotor wash and high winds. A high visibility pocket is located in the center for placement of STAT cards or other triage cards. Each blanket is 46" x 94".

Recalls

Date	Firm	Reason
2024-08-27	Safeguard US Operating LLC	Incorrect expiration date.
2024-08-27	Safeguard US Operating LLC	Incorrect expiration date.
2024-08-27	Safeguard US Operating LLC	Incorrect expiration date.
2021-11-29	Philips North America Llc	After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be
2021-11-29	Philips North America Llc	After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be
2021-11-29	Philips North America Llc	After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be
2021-11-26	Philips North America Llc	After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be
2019-07-08	CooperSurgical, Inc.	The firm updated the IFU in April 2019 to clarify that use of the TRANSWARMER Mattress with other heat producing devices, such as an incubator, is prohibited and could lead to seri
2019-04-26	PF Consumer Healthcare 1 LLC	There is the potential that a HeatWrap could include cells that have a higher cell temperature than specified in lot S97473. The use of heat cell wrap with increased temperatures p
2019-04-26	PF Consumer Healthcare 1 LLC	There is the potential that a HeatWrap could include cells that have a higher cell temperature than specified in lot S97473. The use of heat cell wrap with increased temperatures p

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.