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InhwRior

Shenzhen Yuechuan trade Co., Ltd. · Model RCD · UDI-DI 06978785665100

FNM
10
510(k) clearances
2,643
Adverse events (154 deaths)
13
Recalls
127
Facilities

Description

By utilizing cyclic alternating air inflation and deflation technology, it aims to alleviate localized pressure on the body’s contact areas with the mattress, improve blood circulation in pressured tissues, prevent the formation and progression of pressure ulcers (bedsores), and enhance overall lying comfort during long-term bed confinement.

Recalls

DateFirmReason
2026-01-21Agiliti Health - EllisAgiliti identified an issue where the Adapt Pump (61600200-Adapt Pump) supplied with all Adapt Line support surfaces does not re-engage the Microclimate Management function after u
2025-10-31Stryker Medical Division of Stryker CorporationStryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential inten
2023-11-01Turncare, IncA software issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.
2023-08-10Turncare, IncA software update corrected an issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running p
2021-04-15Getinge (Suzhou) Co LtdThere is a potential for abnormal inflation of the mattress.
2016-07-11American National Mfg IncThe Panacea Air Pro Mattress Control Unit is being recalled due to a firmware problem, which may result in the device not having the firmness range required.
2015-12-03Stryker Medical Division of Stryker CorporationPotential for power cord to melt; hazards include electric shock and fire.
2014-03-18SCM True Air Technologies LLCThe firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.
2010-03-05Encompass Therapeutic Support Systems dba BG North AmericaPotential out gasing of the battery and short term ignition of the gas within the control unit enclosure. This failure mode includes a risk for fire.
2008-10-09Hill-Rom Manufacturing, Inc.These devices have the potential to overheat.

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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.