Affinity® 4 Birthing Bed
Catalogue number P3700E, listed by Hill-ROM, Inc., United States, under Table, Obstetric (And Accessories). 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
2510(k) clearances naming this product code
11recalls on this code
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Kanghui Medical Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 11 |
Record
| Listed by | Hill-ROM, Inc., United States |
|---|---|
| FDA product code | KNC |
| Device type | Table, Obstetric (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4900 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-17 |
| Record revised | 2022-08-05 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P3700E | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Affinity® Surface | Hill-ROM, Inc. | 38 |
| Novo Health Services, LLC | Novo Health Services, LLC | 10 |
| Leg Support | Hill-ROM, Inc. | 2 |
| Calf Support | Hill-ROM, Inc. | 2 |
| Comfort PAD Assembly | Hill-ROM, Inc. | 1 |
| Extension Pad | Hill-ROM, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K924420 | 1993-12-10 |
| K915779 | 1993-02-24 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Baxter Healthcare Corporation | UDI-DI | 2025-05-06 | Class II | Nonconforming Material/Component | There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed. | 164 units |
Recalls
4 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 |
|---|---|---|---|---|---|
| 2021-05-28 | Class II | Device Design | Latch mechanism on the Lift-Off foot section of the Affinity Four Birthing Bed is damaged, it could potentially cause the installed foot section to be improperly engaged onto the bed, could result in injury to the user due to a fall. | 1,096 Beds | 2024-06-06 |
| 2016-07-15 | Class II | Nonconforming Material/Component | 94 beds | 2017-03-23 | |
| 2014-06-26 | Class II | Nonconforming Material/Component | The attachment latch mechanism can become bent depending on user handling. Latch mechanism bending could lead to improper engagement of the foot section and this could result in injury to the user due to a fall. | 13,000 units | 2017-07-14 |
| 2012-04-02 | Class II | Device Design | During review of our last braking system via that field corrective action, the system still did not meet our expectations, which is to eliminate the hazards of patient falling. Bed movement immediately prior to, or during the birthing proce | 12,726 devices | 2015-07-21 |
| 2007-11-21 | Not classified | Device Design | Hole/opening on the labor bar — Amputation of a finger could result, if a finger is placed into the opening, as the hole/opening creates a shear point when the mechanism is activated. | 32,379 for all model numbers | 2009-09-22 |
| 2007-11-21 | Not classified | Device Design | Hole/opening on the labor bar — Amputation of a finger could result, if a finger is placed into the opening, as the hole/opening creates a shear point when the mechanism is activated. | 32,379 for all model numbers | 2009-09-22 |
| 2007-11-21 | Not classified | Device Design | Hole/opening on the labor bar — Amputation of a finger could result, if a finger is placed into the opening, as the hole/opening creates a shear point when the mechanism is activated. | 32,379 for all model numbers | 2009-09-22 |
| 2007-11-21 | Not classified | Device Design | Hole/opening on the labor bar — Amputation of a finger could result, if a finger is placed into the opening, as the hole/opening creates a shear point when the mechanism is activated. | 32,379 for all model numbers | 2009-09-22 |
| 2006-08-18 | Not classified | Other | The cable on the auxiliary outlet may become pinched, which may result in an electrical short with melting of the plastic transformer and the emission of smoke. | 9,324 | 2009-07-14 |
| 2003-04-24 | Not classified | Other | Possible electrical shock hazard, as the power cord grounding pin may break off or become detached. | 2003-09-25 | |
| 2003-04-24 | Not classified | Other | Possible electrical shock hazard, as the power cord grounding pin may break off or become detached. | 2003-09-25 |
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.