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Biodex Medical Systems

TIDI PRODUCTS, LLC · Model 23587 · UDI-DI 00618125157631

MMZ
4
510(k) clearances
26
Adverse events
5
Recalls
16
Facilities

Description

Biodex Medical Systems Urology Drain Bags Vinyl Sterile Fits Hoop Style Urology Frames 1 per Bag

Recalls

DateFirmReason
2017-03-08Sonesta Medical AbThe user / service manual for the Sonesta S2 Chair contain wrong information concerning the maximum patient weight.
2009-11-03Stille ABThere is a potential hazard to the patient if the bolts holding the side rail break, causing the accessories attached at the side rails of the tables and chairs to fall off during
2009-11-03Stille ABThere is a potential hazard to the patient if the bolts holding the side rail break, causing the accessories attached at the side rails of the tables and chairs to fall off during
2009-11-03Stille ABThere is a potential hazard to the patient if the bolts holding the side rail break, causing the accessories attached at the side rails of the tables and chairs to fall off during
2006-10-01Siemens Medical Solutions USA, IncPotential pinch point with the patient 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.