Maquet PowerLED II
PWDII75SFDF VP AIM CL XHS010 K4 081011
6manufacturers in China registered for this device type
1,930catalogue 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 |
| Premarket notification | Exempt |
| Record published | 2022-03-16 |
| Record revised | 2024-12-13 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 60 °C; Handling environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 20 to 75 % RH; Handling environment temperature -10 to 60 °C; Handling environment humidity 20 to 75 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal |
| Distribution end date | 2024-11-07 |
Catalogue Numbers
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Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Lamp, Surgical | Maquet Gmbh | 18 |
| 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
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.