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U.S. Department of Health and Human Services

Class 2 Device Recall Drager PT 4000 Phototherapy System

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  Class 2 Device Recall Drager PT 4000 Phototherapy System see related information
Date Initiated by Firm July 02, 2012
Date Posted July 06, 2012
Recall Status1 Terminated 3 on July 01, 2013
Recall Number Z-1950-2012
Recall Event ID 62470
510(K)Number K954611  
Product Classification Unit, neonatal phototherapy - Product Code LBI
Product Drager PT 4000 Phototherapy System
Code Information 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.
Recalling Firm/
Manufacturer		 Draeger Medical Systems, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact Michael Kelhart
215-721-5400
Manufacturer Reason
for Recall		 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
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 65
Distribution Nationwide Distribution-USA (nationwide) and Puerto Rico.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LBI and Original Applicant = DRAGER, INC.
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