Pro+
PRO+ MRS Surface FOR Versacare® With X-RAY
2manufacturers in China registered for this device type
34catalogue numbers in this listing
7510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| SHL Healthcare Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Guangdong Meicen Medical Equipment Co., Ltd. | Foshan | Guangdong | Manufacturer | 7 |
Record
| Listed by | Hill-ROM, Inc., United States |
|---|---|
| FDA product code | IOQ |
| Device type | Bed, Flotation Therapy, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5170 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-11-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -29 to 60 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P006800A02 | In distribution | |
| P3255A08 | In distribution | |
| P7924A11 | In distribution | |
| P7924A04 | In distribution | |
| P7924ARENT01 | In distribution | |
| P7924ARENT03 | In distribution | |
| P006800A06 | In distribution | |
| P7924A12 | In distribution | |
| P7923A02 | In distribution | |
| P3255A10 | In distribution | |
| P7923A03 | In distribution | |
| P7923A08 | In distribution | |
| P3255A03 | In distribution | |
| P3255ARENT02 | In distribution | |
| P7923A05 | In distribution | |
| P7924A02 | In distribution | |
| P3255A02 | In distribution | |
| P7924ARENT04 | In distribution | |
| P3255A04 | In distribution | |
| P7924A01 | In distribution | |
| P7923A06 | In distribution | |
| P006800A01 | In distribution | |
| P7924A14 | In distribution | |
| P7924ARENT02 | In distribution | |
| P7923A04 | In distribution | |
| P7924A03 | In distribution | |
| P3255A07 | In distribution | |
| P7924A13 | In distribution | |
| P006800A07 | In distribution | |
| P7923A01 | In distribution | |
| P3255A01 | In distribution | |
| P3255ARENT01 | In distribution | |
| P7923A07 | In distribution | |
| P3255A09 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| K-3 Aire-Zone | KAP Medical | 60 |
| Citadel | Arjohuntleigh AB | 53 |
| Bed, Flotation Therapy, Powered | Carilex Medical, Inc. | 44 |
| Multicare | L I N E T spol. s r.o. | 32 |
| K-3oem EZ-Zone | KAP Medical | 30 |
| K-3oem EZ-Aire | KAP Medical | 29 |
| Progressa+ surface | Hill-Rom de México, S. de R.L. de C.V. | 26 |
| Stryker Air | Tridien Medical | 22 |
| Progressa® Surface | Hill-ROM, Inc. | 21 |
| P310 Surface | Hill-ROM, Inc. | 16 |
| TotalCare® P500 Surface | Hill-ROM, Inc. | 13 |
| K-1oemSGS Skinguard MAX | KAP Medical | 13 |
Showing 12 of 74. All products under Bed, Flotation Therapy, Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K143414 | 2015-03-10 |
| K122473 | 2013-06-03 |
| K970636 | 1997-08-26 |
| K964873 | 1997-07-03 |
| K970295 | 1997-05-16 |
| K951001 | 1995-06-27 |
| K945729 | 1995-02-27 |
Recalls Naming This Product
9 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Baxter Healthcare Corporation | UDI-DI | 2024-03-05 | Class II | Under Investigation by firm | Inconsistencies were identified with service records associated with corrections performed for a previous Medical Device Correction issued by Baxter (ref number: FA-2022-026). Your devices have been identified as potentially impacted by the | 232 units |
| Baxter Healthcare Corporation | UDI-DI | 2023-03-31 | Class II | Process change control | There is a potential for mattress cover damage (delamination) which may result in fluid absorption in the mattress (fluid ingress). | 5549 units |
| Baxter Healthcare Corporation | UDI-DI | 2022-06-24 | Class II | Nonconforming Material/Component | 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 from the patient resulting in an increased patient risk of pressure ulcer develo | 200 mattresses |
| Baxter Healthcare Corporation | UDI-DI | 2022-06-24 | Class II | Nonconforming Material/Component | 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 from the patient resulting in an increased patient risk of pressure ulcer develo | 404 mattresses |
| Baxter Healthcare Corporation | UDI-DI | 2022-06-24 | Class II | Nonconforming Material/Component | 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 from the patient resulting in an increased patient risk of pressure ulcer develo | 8 mattresses |
| Baxter Healthcare Corporation | UDI-DI | 2022-06-24 | Class II | Nonconforming Material/Component | 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 from the patient resulting in an increased patient risk of pressure ulcer develo | 202 mattresses |
| Baxter Healthcare Corporation | UDI-DI | 2022-06-24 | Class II | Nonconforming Material/Component | 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 from the patient resulting in an increased patient risk of pressure ulcer develo | 136 mattresses |
| Baxter Healthcare Corporation | UDI-DI | 2022-06-24 | Class II | Nonconforming Material/Component | 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 from the patient resulting in an increased patient risk of pressure ulcer develo | 70 mattresses |
| Baxter Healthcare Corporation | UDI-DI | 2022-06-24 | Class II | Nonconforming Material/Component | 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 from the patient resulting in an increased patient risk of pressure ulcer develo | 9 mattresses |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-05-30 | Class II | Device Design | When the bed is put into the chair egress position, the magnets on the mattress may not hold the bottom of the mattress flat to the bed frame, and the mattress foot section will extend away from the bed at an angle. A patient attempting to | 4,121 Units | 2014-04-17 |
| 2013-02-26 | Class II | Software design | In certain situations a software problem with the TotalCare SpO2RT 2 bed may occur that can lead to inadvertent loss of sufficient surface cushion pressure to adequately support the patient. This may increase the likelihood of skin irritati | 309 | 2014-04-16 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.