Field Safety Notices about OPTI CCA-TS, OPTI CCA-TS2 , OPTI CCA, OPTI-R

According to Swiss Agency for Therapeutic Products, this field safety notices involved a device in Switzerland that was produced by OPTIMedical Systems.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event ID
    Vk_20150414_08
  • Event Date Posted
    2015-04-20
  • Event Country
  • Event Source
    SATP
  • Event Source URL
  • Notes / Alerts
    The data from Switzerland is current through March 2018. All of the data comes from Swiss Agency for Therapeutic Products, 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 Switzerland.
  • Extra notes in the data

Device

  • Model / Serial
    GD7046, GD7013, GD7045, GD7031 | OPTI CCA (GD7045) serial number 8056 and above
    OPTI CCA TS (GD7013) serial number 2700 and above
    OPTI CCA TS2 (GD7046) serial number 1000 and above
    OPTI-R (GD7031) serial number 1334 and above
  • Product Description
    IVD: POC Blood Gas / Electolytes Hardware + acc + cons + software
  • Manufacturer

Manufacturer

  • Source
    SATP