Events

Recall of Device Recall Drager PT 4000 Phototherapy System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Draeger Medical Systems, 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
    62470
  • Event Risk Class
    Class 2
  • Event Number
    Z-1950-2012
  • Event Initiated Date
    2012-07-02
  • Event Date Posted
    2012-07-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110720
  • 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
    Unit, neonatal phototherapy - Product Code LBI
  • Reason
    A routine internal quality check found that the drager pt 4000 phototherapy system is fitted with a 16 amp rated fuse instead of the specified 1.6 amp rated fuse. this may mean that the internal fuse would not trip promptly in the event of an internal short-circuit. the possible consequence is the wall outlet circuit breaker would trip first on the device may severely overheat. there have not b.
  • Action
    Drager Medical Systems sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 2012 to all affected customers. The letter identifies the product, problem, and actions to bee taken by the customers. In addition, a Customer Reply Card was included for customers to complete and return. Contact the firm at 800-543-5047 for questions regarding this recall.

Device

Device Recall Drager PT 4000 Phototherapy System
  • Model / Serial
    Catalog number 2M21700 and serial numbers ASCF-0037 TO ASCF-0061; ASCJ-0037 TO ASCJ-0152; ASCL-0001 TO ASCL-0025; ASCM-0001 TO ASCM-0025; and ASDA-002, 0005, 0006, 0007, 0008, 0009, 0012, 0019, 0025.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution-USA (nationwide) and Puerto Rico.
  • Product Description
    Drager PT 4000 Phototherapy System
  • Manufacturer
    Draeger Medical Systems, Inc.

Manufacturer

Draeger Medical Systems, Inc.
  • Manufacturer Address
    Draeger Medical Systems, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • Manufacturer Parent Company (2017)
    Stefan Dräger GmbH
  • Source
    USFDA