Events

Recall of PRISMALIX (PRX) A CEILING MOUNTED SURGICAL LIGHTING SYSTEM.

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ALM SURGICAL EQUIPMENT INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    15405
  • Event Risk Class
    II
  • Event Initiated Date
    1999-09-16
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Prx main arms missing shaft retaining clips. the clips secure the main arm on the shaft. over time main arm without a clip could become loose and fall on a patient on the operating table.

Device

PRISMALIX (PRX) A CEILING MOUNTED SURGICAL LIGHTING SYSTEM.
  • Model / Serial
    Model Catalog: (Lot serial: 22878.458)
  • Product Description
    ALM Prismalix (PRX)
  • Manufacturer
    ALM SURGICAL EQUIPMENT INC.

Manufacturer

ALM SURGICAL EQUIPMENT INC.
  • Manufacturer Address
    ANAHEIM
  • Source
    HC