Events

Recall of Device Recall Penlon Prima Anaesthesia Machines (SP2 and SP3) with Electronic Flowmeter Display

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

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
    60647
  • Event Risk Class
    Class 2
  • Event Number
    Z-1318-2012
  • Event Initiated Date
    2011-11-29
  • Event Date Posted
    2012-03-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106127
  • 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
    Penlon, ltd has identified the potential for the premature failure of a component in some electronic flowmeter sensor display unit pcb assemblies.
  • Action
    Penlon Limited sent a Technical Bulletin dated November 22, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. As a precaution a field upgrade part was released that required all existing PCB assemblies to be removed and the updated item installed. The old PCB must be returned to Penlon with the serial number of the affected machine. The required replacement parts were included with the technical bulletin. For further information customers should contact the Technical Support Team at techsupport@penlon.com.

Device

Device Recall Penlon Prima Anaesthesia Machines (SP2 and SP3) with Electronic Flowmeter Display
  • Model / Serial
    None
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Peru, Uganda, Kenya, Malaysia, Poland, Saudi Arabia, United Arab Emirates, Philippines, Equador, and Thailand
  • Product Description
    Anesthesia Machines (digital display assembly); || A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.
  • Manufacturer
    Penlon, Ltd.

Manufacturer

Penlon, Ltd.
  • Manufacturer Address
    Penlon, Ltd., Abingdon Science Park, Barton Lane, Abingdon United Kingdom
  • Manufacturer Parent Company (2017)
    BPL Medical Technologies Pvt Ltd.
  • Source
    USFDA