Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Draeger GlobeTrotter and GlobeTrotter IC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Draeger GlobeTrotter and GlobeTrotter IC see related information
Date Initiated by Firm May 20, 2022
Create Date July 12, 2022
Recall Status1 Open3, Classified
Recall Number Z-1365-2022
Recall Event ID 90423
510(K)Number K141565  
Product Classification Incubator, neonatal transport - Product Code FPL
Product Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system
Code Information Model, country, and serial number:  MS20508: El Salvador DSPN-0003  Mexico DSPM-0003, DSPH-0002 Chile DSPL-0003 Saudi Arabia DSPJ-0003, DSPL-0004, DSPL-0005, DSPL-0006, DSPL-0007, DSPM-0001, DSPM-0002, DSPL-0008, DSPK-0002, DSPH-0003, DSPJ-0004, DSRA-0001 Kuwait DSPJ-0002, DSPK-0001 India DSPN-0001, DSPN-0002, DSRA-0002 Taiwan DSPL-0001, SPL-0002, DSPJ-0001  MS20509: Germany DSPH-0003 Qatar DSPL-0007, DSRB-0001 Spain DSPK-0002, DSPJ-0006, DSPJ-0003, DSPH-0001, DSPJ-0004, DSPK-0001, DSPL-0008 Hungary DSPF-0003 Belarus DSPJ-0005 United Kingdom DSPF-0002 Italy DSPJ-0002
Recalling Firm/
Manufacturer		 Draeger Medical Systems, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact Mike Kelhart
215-660-2349
Manufacturer Reason
for Recall		 The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system.
FDA Determined
Cause 2		 Under Investigation by firm
Action On May 20, 2022, the firm began to send Important Field Safety Notice letters to affected customers. Customers were instructed to avoid using the ventilator portion of the system due to the potential for enriched ambient air rising beyond safe levels until a replacement part can be installed and tested. The firm will send customers a replacement kit and testing which will be completed at no charge to the customer. Draeger Service Representatives will call customers and schedule a service visit to update affected systems.
Quantity in Commerce 38 OUS (no US distribution)
Distribution No US distribution. Foreign distribution to BY, CL, DE, ES, GB, HU, IN, IT, KW, MX, SA, SV, TW.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FPL and Original Applicant = Draeger Medical Systems, Inc.
-
-