Z-1950-2012Class II

Drager PT 4000 Phototherapy System

Name: Z-1950-2012 Drager PT 4000 Phototherapy System
Creator: Draeger Medical Systems, Inc.
Published: 2012-07-02
License: https://open.fda.gov/license/

Draeger Medical Systems, Inc. / initiated 2012-07-02 / Terminated

FDA source

Draeger Medical Systems, Inc. began a recall of Drager PT 4000 Phototherapy System on 2012-07-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1950-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-02
Posted: 2012-07-06
Terminated: 2013-07-01
Recalling firm: Draeger Medical Systems, Inc.
Product: Drager PT 4000 Phototherapy System
Product code: LBI Unit, Neonatal Phototherapy
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 root cause: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1950-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1950-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-06

Product code LBI

K954611Class IIDrager Pt4000 Phototherapy SystemDrager, Inc. / cleared 1995-12-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)