Events

Recall of Aisys CS2 Aladin Cassette

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare, LLC.

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
    79493
  • Event Risk Class
    Class 2
  • Event Number
    Z-1199-2018
  • Event Initiated Date
    2017-10-04
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162482
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Gas-machine, anesthesia - Product Code BSZ
  • Reason
    Non-conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.
  • Action
    The firm, GE healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated October 4th, 2017 to all their customers. The letter described the product, problem and actions to be taken. The customers were instructed to contact GE Service to obtain an RMA number. GE Healthcare has arranged with Piramal Inc. to replace the affected products at no cost. If you have any questions or concern regarding this notification please contact GE healthcare Service at 1-800-437-1171 or your local representative.

Device

Aisys CS2 Aladin Cassette
  • Model / Serial
    Model 1100-9034-000 Mfg. Lot or Serial # BGBQ00675 and BGBQ01187
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to states of: AZ, IL NC, NH and PA.
  • Product Description
    DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE || Cassettes are intended to be used to deliver anesthetic agent.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA