Skip to content
Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2013-09-11Z-0027-2014Class IITerminatedFUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket Sensor is not working as intended.Distribution: Worldwide Distribution - USA Nationwide in the states of Florida, Georgia, Oklahoma, Pennsylvania, Tennessee, Texas, West Virginia, and in the country Japan and Italy.10 unitsclearance family
Regulatory clearances
  • 510(k)K113156Substantially equivalent (SESE) · 2011-11-15clearance family

Predicate lineage

Cited as predicate by: K130173, K133454, K161168, K161359

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2012-07-06NAINo action indicatedFujiFilm SonoSite, Inc.0
2010-04-02NAINo action indicatedFujiFilm SonoSite, Inc.0
Similar devices
Select up to two to place side-by-side with this device.