EXPLORER AIR II
SurgVision GmbH · Model 8003 · UDI-DI 04260721460002
Description
EXPLORER AIR® II consists of an imaging system that contains two cameras (one (1) for fluorescence, one (1) for color images) suspended by an articulated arm attached to a trolley. A touch screen and secondary monitor are also mounted on the trolley. EXPLORER AIR® II enhances the surgeon’s vision with use of near infrared fluorescence (NIR) imaging. The technology is based on the exposure of the tissue of interest to light after fluorescent dye such as indocyanine green (ICG) or pafolacianine has been administered to the patient. The EXPLORER AIR® II visualizes fluorescence excited by infrared light (740-760nm) and emitted in the band around 800nm. After image acquisition, the composite image (overlay of fluorescence and color images) is displayed along with the fluorescent and color images. The user can tag and compare images, play the recorded videos, and export the selected files. The EXPLORER AIR® II must be used with EXPLORER AIR® Sterile Drape for use under sterile conditions. The EXPLORER AIR® Sterile Drape is manufactured by Exact Medical Manufacturing, Inc., and has been cleared in K101689.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-18 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure a |
| 2021-12-16 | Shimadzu Medical Systems | Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in |
| 2020-11-18 | Shimadzu Medical Systems | The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after |
| 2020-11-18 | Shimadzu Medical Systems | The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after |
| 2019-12-30 | Philips North America, LLC | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible |
| 2019-12-30 | Philips North America, LLC | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible |
| 2019-04-09 | Siemens Medical Solutions USA, Inc | In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement. |
| 2019-04-09 | Siemens Medical Solutions USA, Inc | In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement. |
| 2019-04-09 | Siemens Medical Solutions USA, Inc | In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement. |
| 2019-04-09 | Siemens Medical Solutions USA, Inc | In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement. |
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