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Bed, Air Fluidized
FDA product code INX · Class 2 · Physical Medicine
16
Registered devices
1,460
Adverse events
9
Recalls
28
510(k) clearances
Devices with this code
AFCS PEARLS™ Filter sheet small multifilament — Synergie Nederland B.V.AFCS PEARLS™ Air filter — Synergie Nederland B.V.Envella™ Bed — HILL-ROM, INC.AFCS PEARLS™ Traction support pole — Synergie Nederland B.V.HYDROAIRE — AURORA MANUFACTURING, LLCAFCS PEARLS™ Bed unit — Synergie Nederland B.V.Patient Helper — HILL-ROM, INC.AFCS PEARLS™ Extension Hose — Synergie Nederland B.V.AFCS PEARLS™ Filter sheet large multifilament — Synergie Nederland B.V.AFCS PEARLS™ Filter sheet large monofilament — Synergie Nederland B.V.HYDROAIRE — AURORA MANUFACTURING, LLCAFCS PEARLS™ Backrest — Synergie Nederland B.V.AFCS PEARLS™ & SANDS™ Corner clamps — Synergie Nederland B.V.AFCS PEARLS™ Control unit — Synergie Nederland B.V.AFCS PEARLS™ Control unit — Synergie Nederland B.V.AFCS PEARLS™ Filter sheet small monofilament — Synergie Nederland B.V.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-02-03 | Hill-Rom, Inc. | The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed headboards failed to meet the safety standard force requirements. |
| 2012-02-03 | Hill-Rom, Inc. | The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed headboards failed to meet the safety standard force requirements. |
| 2009-06-24 | Hill-Rom Manufacturing, Inc. | Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed. |
| 2009-06-24 | Hill-Rom Manufacturing, Inc. | Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed. |
| 2004-03-22 | Kinetic Concepts, Inc | Battery outgassing of powered hospital beds |
| 2003-05-05 | Hill-Rom Manufacturing, Inc. | Malfunction of side-rail latching pin coupled with inadequate directions for use. |
| 2003-05-05 | Hill-Rom Manufacturing, Inc. | Malfunction of side-rail latching pin coupled with inadequate directions for use. |
| 2002-01-14 | Hill-Rom Manufacturing, Inc. | Power cord overheating |
| 1997-06-01 | Kinetic Concepts, Inc | Battery out-gassing due to battery over charging and/or secondary failure mode of deep-discharge. |
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