Lamp, Surgical
Power Supply LCA 1 C US
6manufacturers in China registered for this device type
18catalogue numbers in this listing
6recalls on this code
Who Else Makes It
Concentrated in Guangdong (2), Shanghai (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Huifeng Medical Instrument Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Dragon Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| HI-Life Technology (Hebei) Co., Ltd. | Bazhou | Hebei | Manufacturer | 11 |
| Shenzhen Youmay Electronics Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 10 |
| Shanghai PAX Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
Record
| Listed by | Maquet Gmbh, Germany |
|---|---|
| FDA product code | FTD |
| Device type | Lamp, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4580 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K130513 |
| Record published | 2016-09-14 |
| Record revised | 2022-05-16 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 20 to 75 % RH; Handling environment temperature -10 to 60 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 20 to 75 % RH; Storage environment temperature -10 to 60 °C |
| Distribution end date | 2022-03-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ARD569067999 | In distribution | |
| ARD569061999 | In distribution | |
| ARD569060999 | In distribution | |
| ARD567355901 | In distribution | |
| ARD567355940 | In distribution | |
| ARD569064999 | In distribution | |
| ARDDIV000000A | In distribution | |
| ARD569070999 | In distribution | |
| ARD567355958 | In distribution | |
| ARD567203901 | In distribution | |
| ARD569063999 | In distribution | |
| ARD569065999 | In distribution | |
| ARD567355968 | In distribution | |
| ARD569068999 | In distribution | |
| ARD567355960 | In distribution | |
| ARD567355964 | Withdrawn | |
| ARD567355970 | Withdrawn | |
| ARD567355966 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Maquet PowerLED II | Maquet Gmbh | 1,930 |
| S300 Series | Dentis Co., Ltd. | 41 |
| Standop Volista® | Maquet Gmbh | 32 |
| L400 Series | Dentis Co., Ltd. | 24 |
| M400 Series (Ceiling, Mobile) | Dentis Co., Ltd. | 24 |
| Maquet Ezea | Maquet Gmbh | 18 |
| Maisilide | Shandong Deman Medical Equipment Group Co., Ltd. | 15 |
| S250 Series(Ceiling, Mobile) | Dentis Co., Ltd. | 11 |
| Lucea LED® | Maquet Gmbh | 7 |
| StarTrol | Huot Instruments, LLC | 7 |
| Rolite Volista Standop | Maquet Gmbh | 5 |
| Lewin | Shandong Lewin Medical Equipment Co., Ltd. | 5 |
Showing 12 of 52. All products under Lamp, Surgical
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. | 39 | 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. | 3 | 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. | 1 | 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. | 166 | 2012-06-04 |
| 2009-02-23 | Not classified | Device Design | The screws holding the Prismatic triple surgical lights may break due to dynamic multidirectional bending stress. The firm has received one complaint report. | 54 of all units, both article numbers | 2009-09-29 |
| 2009-02-23 | Not classified | Device Design | The screws holding the Prismatic triple surgical lights may break due to dynamic multidirectional bending stress. The firm has received one complaint report. | 54 of all units, both article numbers | 2009-09-29 |
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.