Home › Device types › IOQ
Bed, Flotation Therapy, Powered
FDA product code IOQ · Class 2 · Physical Medicine
641
Registered devices
1,216
Adverse events
38
Recalls
57
510(k) clearances
Devices with this code
Progressa+ surface — Hill-Rom de México, S. de R.L. de C.V.NA — CARILEX MEDICAL, INC.DuoGard — STRYKER CORPORATIONP310 Surface — HILL-ROM, INC.K-3oem EZ-ZONE — KAP MEDICALK-1oemSG SKINGUARD MAX — KAP MEDICALProgressa+ surface — Hill-Rom de México, S. de R.L. de C.V.Patient Helper — HILL-ROM, INC.Progressa® Surface — HILL-ROM, INC.pro+ — HILL-ROM, INC.Citadel — Arjohuntleigh ABSofCare — STRYKER CORPORATIONK-1oemSGS SKINGUARD MAX — KAP MEDICALTotalCare® P500 Surface — HILL-ROM, INC.K-3oem EZ-AIRE — KAP MEDICALCitadel — Arjohuntleigh ABK-3 AIRE-ZONE — KAP MEDICALP500 Surface — HILL-ROM, INC.Citadel — Arjohuntleigh ABK-3 AIRE-ZONE — KAP MEDICALNA — CARILEX MEDICAL, INC.Citadel — Arjohuntleigh ABK-0 SGS SKINGUARD — KAP MEDICALTotalCare®Bariatric Plus Surface — HILL-ROM, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-18 | Baxter Healthcare Corporation | There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved pro |
| 2026-08-18 | Baxter Healthcare Corporation | There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved pro |
| 2026-08-18 | Baxter Healthcare Corporation | There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved pro |
| 2025-02-25 | Baxter Healthcare Corporation | The air bladders inside the mattress may move out of position when the head of the bed is elevated, causing a dip in the mattress. |
| 2024-05-08 | Baxter Healthcare Corporation | There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropria |
| 2024-03-05 | Baxter Healthcare Corporation | Inconsistencies were identified with service records associated with corrections performed for a previous Medical Device Correction issued by Baxter (ref number |
| 2023-10-04 | Baxter Healthcare Corporation | Progressa+ beds have the potential for static buildup from the casters and/or power drive. This static electricity could be passed to the operator through the t |
| 2023-03-31 | Baxter Healthcare Corporation | There is a potential for mattress cover damage (delamination) which may result in fluid absorption in the mattress (fluid ingress). |
| 2022-06-24 | Baxter Healthcare Corporation | The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away |
| 2022-06-24 | Baxter Healthcare Corporation | The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away |
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