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Bone Profiler

Megagen Implant Co. Ltd · Model ARIBP60G · UDI-DI 08800293007784

MDP Prescription
0
510(k) clearances
227
Adverse events (8 deaths)
3
Recalls
7
Facilities

Description

Ø6

Recalls

DateFirmReason
2026-01-06VANTIVE US HEALTHCARE LLCThere is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
2014-07-18Gambro Renal Products, IncorporatedGambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
2014-07-18Gambro Renal Products, IncorporatedGambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

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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.