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FL400 / FL560

Leica Microsystems (Schweiz) AG · Model 000000000010448796 · UDI-DI 07630003579482

IZI Prescription

510(k) clearances

7,625

Adverse events (85 deaths)

259

Recalls

147

Facilities

Description

FL400 / FL560 for M530 - Accessory for Leica surgical operating microscope systems

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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.