Rolite Volista Access
VCS60 ROL B
5manufacturers in China registered for this device type
3catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Concentrated in Guangdong (2), Shandong (1), Jiangxi (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Kaiyan Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Guangdong Kareway Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 16 |
| Shandong Deman Medical Equipment Group Co., Ltd. | Jining | Shandong | Manufacturer | 11 |
| Nanchang Micare Medical Equipment Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 8 |
Record
| Listed by | Maquet Gmbh, Germany |
|---|---|
| FDA product code | FSY |
| Device type | Light, Surgical, Ceiling Mounted |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4580 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K130513 |
| Record published | 2016-09-16 |
| Record revised | 2024-12-11 (version 8) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2021-08-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ARDROL309029A | Withdrawn | |
| ARDROL309028A | Withdrawn | |
| ARDROL309024A | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HarmonyAIR | Steris Corporation | 1,344 |
| Volista | Maquet Gmbh | 677 |
| iCE Surgical Light | Amico Clinical Solutions | 599 |
| Powerled TM | Maquet Gmbh | 287 |
| Devon | Cardinal Health | 70 |
| Light, Surgical, Ceiling Mounted | Maquet Gmbh | 68 |
| Alyon | Steris Corporation | 64 |
| Medical Boom | Amico Clinical Solutions | 56 |
| Standop Volista® | Maquet Gmbh | 50 |
| Amtai | Amtai Medical Equipment, Inc. | 45 |
| Mira Minor Surgery Light | Amico Lights Corporation | 24 |
| MI Product Line | Medical Illumination International, Inc | 20 |
Showing 12 of 191. All products under Light, Surgical, Ceiling Mounted
Recalls Naming This Product
19 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 |
|---|---|---|---|---|---|---|---|
| Getinge Usa Sales Inc | 510(k) number | 2023-11-08 | Class II | Equipment maintenance | A potential for a light system to fall in the operating room. | 236793 units in total | |
| Getinge Usa Sales Inc | 510(k) number | 2022-05-06 | Class II | Process change control | Paint particles may detach and fall in the operating field. In the worst case scenario, infection, organ irritation, hypersensitivity reaction, and tissue granuloma may result if paint particles fall during surgical operation into the patie | 337 (US); 8594 (OUS) | |
| Maquet Cardiovascular Us Sales, Llc | 510(k) number | 2019-05-28 | Class II | Device Design | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection | 2 units | 2023-07-10 |
| Maquet Cardiovascular Us Sales, Llc | 510(k) number | 2019-05-28 | Class II | Device Design | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection | 11 units | 2023-07-10 |
| Maquet Cardiovascular Us Sales, Llc | 510(k) number | 2019-05-28 | Class II | Device Design | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection | 65 units | 2023-07-10 |
| Maquet Cardiovascular Us Sales, Llc | 510(k) number | 2019-05-28 | Class II | Device Design | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection | 46 units | 2023-07-10 |
| Maquet Cardiovascular Us Sales, Llc | 510(k) number | 2019-05-28 | Class II | Device Design | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection | 7 units | 2023-07-10 |
| Maquet Cardiovascular Us Sales, Llc | 510(k) number | 2019-05-28 | Class II | Device Design | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection | 2 units | 2023-07-10 |
| Maquet Cardiovascular Us Sales, Llc | 510(k) number | 2019-05-28 | Class II | Device Design | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection | 6 units | 2023-07-10 |
| Maquet Cardiovascular Us Sales, Llc | 510(k) number | 2019-05-28 | Class II | Device Design | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection | 12 units | 2023-07-10 |
| Maquet Cardiovascular Us Sales, Llc | 510(k) number | 2019-05-28 | Class II | Device Design | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection | 11 units | 2023-07-10 |
| Maquet Cardiovascular Us Sales, Llc | 510(k) number | 2019-05-28 | Class II | Device Design | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection | 5 units | 2023-07-10 |
| Maquet Cardiovascular Us Sales, Llc | 510(k) number | 2019-05-28 | Class II | Device Design | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection | 2 units | 2023-07-10 |
| Maquet Cardiovascular Us Sales, Llc | 510(k) number | 2019-05-28 | Class II | Device Design | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection | 9 units | 2023-07-10 |
| Maquet Cardiovascular Us Sales, Llc | 510(k) number | 2019-05-28 | Class II | Device Design | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection | 10 units | 2023-07-10 |
| Maquet S.A.S. | 510(k) number | 2018-06-14 | Class II | Process control | Certain VOLISTA StandOP Surgical Lights have been identified as having a potential light head detachment issue. Improper assembly of the bracket that connects the light head to the axle fork could result in the light head bracket breaking, | 151 | 2022-06-23 |
| Maquet S.A.S. | 510(k) number | 2018-04-19 | Class II | Device Design | Potential keypad failure on VOLISTA StandOP Surgical Lights. | 187 | 2020-11-18 |
| Getinge US Sales LLC | 510(k) number | 2018-02-07 | Class II | Component design/selection | The manufacturer received complaints indicating that the device’s central handle holder detaches easily from the handle holder ring on the light head during clinical use. In the event of such detachment, particles from the handle holder rin | 5214 | 2021-09-02 |
| Maquet Cardiovascular Us Sales, Llc | 510(k) number | 2015-05-29 | Class II | Device Design | Maquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light Systems may grind at the junction of the suspension arms which can cause paint chips or particles to fall into the surgical field, when the suspension arms are mounted a | 646 units | 2017-04-07 |
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 |
|---|---|---|---|---|---|
| 2009-10-07 | Not classified | Device Design | Several reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various Manufacturers. All incidents pertain to a crack on the front joint of the Acrobat arm. | 54 | 2012-06-04 |
| 2009-10-07 | Not classified | Device Design | Several reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various Manufacturers. All incidents pertain to a crack on the front joint of the Acrobat arm. | 346 | 2012-06-04 |
| 2009-10-07 | Not classified | Device Design | Several reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various Manufacturers. All incidents pertain to a crack on the front joint of the Acrobat arm. | 331 | 2012-06-04 |
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.