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Claymount

Varex Imaging Nederland B.V. · Model 50250-13-OEM · UDI-DI 08718755000382

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510(k) clearances

Adverse events

Recalls

Facilities

Description

x-ray beam-limiting device, to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(Collimator) This is a device out of the Optica 20 series

Recalls

Date	Firm	Reason
2011-10-28	Shimadzu Medical Systems	Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standard
2007-08-10	Summit Industries Inc.	The D800 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table.
2007-08-10	Summit Industries Inc.	The E600 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table.
2007-08-10	Summit Industries Inc.	The F100 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table.

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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.