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Claymount

Varex Imaging Nederland B.V. · Model 50126-27-OEM · UDI-DI 08718755000511

IZW Prescription

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 40 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
2008-02-07	Philips Medical Systems North America Co. Phillips	The collimator could fall from the x-ray stand, due to loosening screws, and strike a patient or operator underneath.
2007-03-15	Philips Medical Systems North America Co. Phillips	The Collimator field-defining light beam does not meet the light field contrast ratio requirement of 4:1. System is non-compliant with performance standard (1020.31 (d)(2)(iii) 21

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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.