Mattress, Air Flotation, Alternating Pressure
General Hospital · 21 CFR 880.5550
Recent MDR events
2,524 adverse event reports on file
- Nimbus ProfessionalJul 31, 2026MalfunctionArjo (suzhou) Co., Ltd.3005619970-2026-00023
- Nimbus ProfessionalJul 31, 2026MalfunctionArjo (suzhou) Co., Ltd.3005619970-2026-00024
- MEDLINEJul 31, 2026MalfunctionMedline Industried Lp1417592-2026-08130
- Drive Medical MedAire8 LowAirLoss.w/Pump systemJul 29, 2026InjuryGrand Healthcare Co. Ltd2438477-2026-00050
- RAYE'S, Inc dba Sizewise ManufacturingJul 28, 2026InjuryAgiliti Health - Ellis1954156-2026-00006
- K-4oem SkinguardJul 27, 2026InjuryKap Medical3003083675-2026-00001
- MEDLINEJul 22, 2026MalfunctionMedline Industried Lp1417592-2026-07506
- AURAJul 21, 2026MalfunctionArjo (suzhou) Co., Ltd.3005619970-2026-00022
- NIMBUS 4Jul 21, 2026MalfunctionArjo (suzhou) Co., Ltd.3005619970-2026-00021
- AIRONE APP ALTERNATING PRESSURE PUMP AND PADJul 21, 2026MalfunctionMedline Industries, Lp1417592-2026-07077
Event type breakdown
Recalls
13 recall events for this product code
- Agiliti Health - EllisOpen, ClassifiedFeb 26, 2026
Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Adapt Air Pro, Adapt Air Pro EX, Adapt Conv
Agiliti 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 using the Autofirm function for 10 minutes. This issue only occurs when the 10-minute timer is allowed to elapse after the Autofirm button is pressed after initial setup, and it only affects the Microclimate Management function.
Z-1472-2026 · View FDA record ↗ - Stryker Medical Division of Stryker CorporationOpen, ClassifiedDec 11, 2025
Stryker Arise 1000EX mattress, Part Number 2236000000
Stryker 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 intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker.
Z-0919-2026 · View FDA record ↗ - Turncare, IncOpen, ClassifiedJun 12, 2025
Brand Name: Guardian 2 System
A 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.
Z-1967-2025 · View FDA record ↗ - Turncare, IncOpen, ClassifiedJun 12, 2025
Brand Name: Guardian 2 System
A 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 patient therapy.
Z-1968-2025 · View FDA record ↗ - Stryker Medical Division of Stryker CorporationTerminatedMar 8, 2016
Stryker Position Pro Mattress.
Potential for power cord to melt; hazards include electric shock and fire.
Z-1081-2016 · View FDA record ↗ - SCM True Air Technologies LLCTerminatedMay 19, 2014
MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.
Z-1632-2014 · View FDA record ↗ - Encompass Therapeutic Support Systems dba BG North AmericaTerminatedMar 31, 2010
AccuMax Quantum Complete (Model CU3/CU4), an alternating pressure with turn assist & on demand low air loss system; Encompass Therapuetic Support Systems, Glend
Potential 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.
Z-1216-2010 · View FDA record ↗ - Hill-Rom Manufacturing, Inc.TerminatedJan 7, 2009
Synergy Pulse, Powered Flotation Therapy bed, Model number 5609.
These devices have the potential to overheat.
Z-0600-2009 · View FDA record ↗ - Hill-Rom Manufacturing, Inc.TerminatedJan 7, 2009
Synergy Dynamic, Powered Patient Rotation Bed, Model number 5607.
These devices have the potential to overheat.
Z-0601-2009 · View FDA record ↗ - Hill-Rom Manufacturing, Inc.TerminatedJan 7, 2009
Synergy Air Squared, Alternating Pressure Air Flotation Mattress, Model number 6361.
These devices have the potential to overheat.
Z-0602-2009 · View FDA record ↗
Registered firms
127 firms currently registered for this product code
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
Zhejiang Shininglion Technology Co.,ltd
Huzhou City Zhejiang, CN
Levisense Medical, Inc.
Beverly, MA, US
Rasmussen De Tecate S.a. De C.v.
Tecate Baja California, MX
Better Medical Technology Co., Ltd.
Foshan City Guangdong, CN
Valmar Surgical Supplies, Inc.
Lakewood, NJ, US
Drive Devilbiss Healthcare
Dayton, NJ, US
Jiangsu Mcare Medical Co.,ltd.
Danyang Jiangsu, CN
Emerald Supply
Brooklyn, NY, US
Arjohuntleigh Polska Sp. Zo.o.
Poznan Wielkopolskie, PL
Compass Health Brands (corporate Office)
Middleburg Heights, OH, US
Guangdong Yuehua Medical Instrument Factory Co., Ltd.
Shantou Guangdong, CN
Apex Medical (kunshan) Corp.
Kunshan City Jiangsu, CN
Foshan Maikang Medical Equipment Co., Ltd
Foshan Guangdong, CN
Joerns Healthcare Brownsville
Brownsville, TX, US
Drive Devilbiss Healthcare
Palmetto, GA, US
Xiamen Ortocare Sports Health Co.,ltd.
Xiamen Free Trade Zone Fujian, CN
Care&care Health Products Co., Ltd
Yuanli Township Miaoli, TW
Cross Innovations Llc
Cheyenne, WY, US
Foshan Feiyang Medical Equipment Co., Ltd.
Foshan Guangdong, CN
Proactive Medical Products
Mount Vernon, NY, US
Shanghai No. 2 Medical College Duhang Medical Equipment Factory
Shanghai, CN
Zhejiang Mateside Medical Devices Technology Co., Ltd
Ningbo Zhejiang, CN
Guangdong Kareway Medical Technology Co., Ltd
Foshan Guangdong, CN
Zhongshan First Medical Equipment Co., Ltd
Zhongshan Guangdong, CN
510(k) clearances
102 clearances for this product code
- Span-America Medical Systems, Inc.Feb 20, 1998
K973169 · PRESSURE GUARD SITE SELECT (A)
- Cardio Systems, Inc.Jan 22, 1998
K972022 · ZAK-2000
- Wheelchairs of KansasJan 22, 1998
K974319 · MIGHTY AIR
- Physio Designs, Inc.Jan 6, 1998
K974070 · PHYSIO/1000
- Kinetic Concepts, Inc.Nov 18, 1997
K972549 · SIMPULSE
- Cathay Consolidated, Inc.Nov 7, 1997
K970081 · SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM
- Kinetic Concepts, Inc.Oct 23, 1997
K955243 · BARIAIR
- Kinetic Concepts, Inc.Sep 5, 1997
K970468 · KT AIR BED