DRX-Revolution Mobile X-Ray System
Tube-Grid Align SYS FOR DRX-Revolution
5manufacturers in China registered for this device type
7catalogue numbers in this listing
7510(k) clearances naming this product code
13recalls on this code
Who Else Makes It
Concentrated in Beijing (2), Shanghai (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Shantou Institute OF Ultrasonic Instruments Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 8 |
| Suzhou Powersite Electric Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Carestream Health, Inc., United States |
|---|---|
| FDA product code | IZL |
| Device type | System, X-Ray, Mobile |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1720 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K120062 |
| Record published | 2020-06-10 |
| Record revised | 2026-05-13 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2021-11-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DRX-Revolution Mobile X-ray System | In distribution | |
| DRX-Revolution Mobile X-ray System | In distribution | |
| DRX-Revolution Mobile X-ray System | In distribution | |
| DRX-Revolution Mobile X-ray System | In distribution | |
| DRX-Revolution Mobile X-ray System | Withdrawn | |
| DRX-Revolution Mobile X-ray System | Withdrawn | |
| DRX-Revolution Mobile X-ray System | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Siui | Shantou Institute OF Ultrasonic Instruments Co., Ltd. | 27 |
| AcuityPDR | RadmediX, LLC | 24 |
| Sedecal | Sedecal., Sa. | 20 |
| Drgem | Drgem Corporation | 10 |
| MinXray | Minxray, Inc. | 6 |
| System, X-Ray, Mobile | Ecotron Co., Ltd. | 6 |
| MobileDaRt Evolution | Shimadzu Corp. | 5 |
| Nomad MD™ handheld X-ray system | Aribex, Inc. | 5 |
| Portable X-ray Unit | Ajex Meditech., Ltd. | 5 |
| Diagnostic X-ray Unit | Poskom Co., Ltd. | 4 |
| FDR Aqro | Fujifilm Corporation | 4 |
| Optima | GE Medical Systems, L.L.C. | 4 |
Showing 12 of 75. All products under System, X-Ray, Mobile
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253185 | 2026-03-11 |
| K241505 | 2024-12-10 |
| K213568 | 2022-03-23 |
| K191025 | 2019-05-17 |
| K173924 | 2018-02-05 |
| K170755 | 2017-06-21 |
| K120062 | 2012-04-13 |
Recalls Naming This Product
9 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Carestream Health, Inc. | UDI-DI | 2023-10-02 | Class II | Component design/selection | There is a potential for unexpected failure of the electrical components within the Carestream Health Inc. generator installed in your DRX-Revolution Mobile X-ray System(s). This can lead to temporary and self contained thermal overload wit | 2402 systems | |
| Carestream Health, Inc. | UDI-DI | 2023-10-02 | Class II | Component design/selection | Unexpected failure of electrical components within the CPI generator. | 3,961 units | |
| Carestream Health, Inc. | 510(k) number | 2017-05-25 | Class II | Process control | Carestream found a single unit where four screws in the assembly were not applied in the manufacturing process. This could result in separation of the tube and yoke assembly. | Domestic: 1449 units; Foreign: 1416 units | 2018-06-13 |
| Carestream Health, Inc. | 510(k) number | 2017-01-12 | Class II | Device Design | The firm received a complaint alleging that a DRX Revolution System could not be stopped when applying the brake. The Revolution crashed into an elevator. | US: 1403 units; Foreign: 1370 units | 2018-06-13 |
| Carestream Health, Inc. | 510(k) number | 2014-11-25 | Class II | Device Design | While servicing a unit at a customer site, a field engineer discovered a broken bolt from the carriage assembly. Carestream has identified an issue related to the DRX-Revolution Mobile X-Ray System in which bolts that secure the x-ray tube | 629 units (Domestic: 358 units; Foreign: 271 units) | 2016-06-06 |
| Carestream Health, Inc. | 510(k) number | 2013-08-29 | Class II | Software design | Carestream Health Inc. has conducted a voluntary field action which includes the installation of a software patch on the following: DRX-Revolution Mobile X-Ray, DRX-Mobile and DRX Transportable Systems with DirectView Version 5.5 and 5.6 co | 190 units | 2016-06-28 |
| Carestream Health, Inc. | 510(k) number | 2013-07-26 | Class II | Software design | During an audit, Carestream discovered a DRX-1 System that captured an image which displayed an artifact. This issue was discovered in manufacturing. It occurs when the DRX product console software is updated to v5.6b software and the det | 23 units installed total (11 domestically & 12 international | 2016-05-25 |
| Carestream Health, Inc. | 510(k) number | 2013-06-19 | Class II | Device Design | Carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolution Mobile X-Ray System due to the cover dislodging from the column. | 331 units | 2016-05-20 |
| Carestream Health, Inc. | 510(k) number | 2013-06-06 | Class II | Device Design | Carestream Health Inc. is recalling the power plug on their DRX-Revolution Mobile X-Ray System due to the item generating sparks and becoming warm to touch. | 180 units | 2016-05-20 |
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 |
|---|---|---|---|---|---|
| 2013-11-25 | Class II | Nonconforming Material/Component | Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement. | 493 units Total (107 units domestically & 386 units internat | 2016-06-30 |
| 2013-11-25 | Class II | Nonconforming Material/Component | Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement. | 840 units Total (181 units domestically & 659 units internat | 2016-06-30 |
| 2013-11-25 | Class II | Nonconforming Material/Component | Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement. | 675 units Total (145 units domestically & 530 units internat | 2016-06-30 |
| 2013-08-29 | Class II | Radiation Control for Health and Safety Act | It was discovered that Carestream received a report from a customer that 2 different patients were re-exposed due to the fact that the processed images were not able to be found in the system. | 310 systerms domestically | 2015-11-18 |
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.