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Ralco srl

RALCO SRL · Model R 108 DHHS · UDI-DI 08058776050035

IZX Prescription
10
510(k) clearances
5
Adverse events
4
Recalls
13
Facilities

Recalls

DateFirmReason
2011-10-28Shimadzu Medical SystemsShimadzu 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
2007-08-10Summit Industries Inc.The D800 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table.
2007-08-10Summit Industries Inc.The E600 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table.
2007-08-10Summit 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.