Medstone
Examination and procedure table
2manufacturers in China registered for this device type
17catalogue numbers in this listing
1recall
Who Else Makes It
All of them in Beijing.
| 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 |
Record
| Listed by | Stille AB, Sweden |
|---|---|
| FDA product code | IXR |
| Device type | Table, Radiographic, Tilting |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1980 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-01-22 |
| Record revised | 2021-03-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Distribution end date | 2020-09-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Medstone5 ERCP | In distribution | |
| Medstone3 CT | In distribution | |
| Medstone5 ERCP KIT | In distribution | |
| Medstone3 PM | In distribution | |
| Medstone3 CV | In distribution | |
| Medstone3 PM | In distribution | |
| Medstone2 PM | In distribution | |
| Medstone2 PM | In distribution | |
| Medstone3 ERCP | In distribution | |
| Medstone5 CV | In distribution | |
| Medstone3 ERCP KIT | In distribution | |
| Medstone1 PM | In distribution | |
| Medstone2 PM | In distribution | |
| Medstone3D | In distribution | |
| Medstone4 PM | Withdrawn | |
| Medstone5 PM | Withdrawn | |
| Medstone4 PM | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Oakworks Medical | Oakworks, Inc. | 265 |
| Image Diagnostics Inc | Image Diagnostics, Inc. | 41 |
| Aadco | Aadco Medical, Inc. | 28 |
| Surgical C Arm Table | Biodex Medical Systems, Inc. | 12 |
| Aadco Imaging Table | Aadco Medical, Inc. | 4 |
| Sonesta | Sonesta Medical AB | 2 |
| LF | Liebel-Flarsheim Company LLC | 2 |
| Urology C Arm Table | Biodex Medical Systems, Inc. | 2 |
| Brachytherapy Table | Biodex Medical Systems, Inc. | 2 |
| ZS-100IR | Shimadzu Corp. | 2 |
| YSF-300 | Shimadzu Corp. | 2 |
| Sonesta F3 | Sonesta Medical AB | 2 |
Showing 12 of 22. All products under Table, Radiographic, Tilting
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2008-08-27 | Not classified | Component design/selection | The table contains a battery backup, not mentioned in the User Manual, which automatically will provide power to the electrical actuators/motions in case of a power loss from the main power supply. However, if a short circuit occurs, it ca | 114 units | 2010-12-10 |
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.