Philips Medical Systems DMC
Catalogue number Juno DRF, listed by Villa Sistemi Medicali SPA, under Device, Beam Limiting, X-Ray, Diagnostic. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Fairy Medical Electrics(Jiaxing)Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 3 |
Record
| Listed by | Villa Sistemi Medicali SPA |
|---|---|
| FDA product code | KPW |
| Device type | Device, Beam Limiting, X-Ray, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1610 |
| 510(k) | K050190 |
| Record published | 2016-09-24 |
| Record revised | 2019-08-05 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2019-07-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Juno DRF | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ralco srl | Ralco SRL | 10 |
| Villa Sistemi Medicali | Villa Sistemi Medicali SPA | 2 |
| X-ray beam limiting device | Canon Inc. | 1 |
| Device, Beam Limiting, X-Ray, Diagnostic | Yoshida Denzai Kogyo Co., Ltd. | 1 |
| Collimator AL02 II eL | Siemens Healthcare Limited | 1 |
| X-ray Beam Filter Kit | Carestream Health, Inc. | 1 |
| Collimator ML01 II | Siemens Healthcare Limited | 1 |
Recalls Naming This Product
14 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Villa Sistemi Medicali S.P.A. | 510(k) number | 2019-11-04 | Class II | Device Design | An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditi | 46 | |
| Villa Sistemi Medicali S.P.A. | 510(k) number | 2019-11-04 | Class II | Device Design | An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditi | 3 | |
| Villa Sistemi Medicali S.P.A. | 510(k) number | 2019-11-04 | Class II | Device Design | An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditi | 7 | |
| Villa Sistemi Medicali S.P.A. | 510(k) number | 2019-11-04 | Class II | Device Design | An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditi | 1 | |
| Villa Sistemi Medicali S.P.A. | 510(k) number | 2016-12-27 | Class II | Nonconforming Material/Component | Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position. | 65 devices in total | 2021-03-09 |
| Villa Sistemi Medicali S.P.A. | 510(k) number | 2016-12-27 | Class II | Nonconforming Material/Component | Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position. | 65 devices in total | 2021-03-09 |
| Villa Sistemi Medicali S.P.A. | 510(k) number | 2016-12-27 | Class II | Nonconforming Material/Component | Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position. | 65 devices in total | 2021-03-09 |
| Villa Sistemi Medicali S.P.A. | 510(k) number | 2016-12-27 | Class II | Nonconforming Material/Component | Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position. | 65 devices in total | 2021-03-09 |
| Acteon, Inc. | 510(k) number | 2016-02-19 | Class II | Device Design | The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) T | 66 distributed in US | |
| Acteon, Inc. | 510(k) number | 2016-02-19 | Class II | Device Design | The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) T | 66 distributed in US | |
| Acteon, Inc. | 510(k) number | 2016-02-19 | Class II | Device Design | The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) T | 66 distributed in US | |
| Acteon, Inc. | 510(k) number | 2016-02-19 | Class II | Device Design | The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) T | 66 distributed in US | |
| Acteon, Inc. | 510(k) number | 2014-12-14 | Class II | Radiation Control for Health and Safety Act | The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality | 30 units distributed in the US | 2017-03-16 |
| Acteon, Inc. | 510(k) number | 2013-08-02 | Class II | Radiation Control for Health and Safety Act | It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30×30 (12″x12″) and 15×15 (6″x6). This could result in a deviation of the displayed values of Air Kerma Rate and Cumulated Air Kerma from | 22 units within US | 2016-07-25 |
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.