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Terminated

Drager PT 4000 Phototherapy System

FDA Recall Z-1950-2012 · Posted 2012-07-06

Recalling FirmDraeger Medical Systems, Inc.
Recall StatusTerminated
Product CodeLBI
Date Initiated2012-07-02
Date Terminated2013-07-01
Product Quantity65

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

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide Distribution-USA (nationwide) and Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K954611DRAGER PT4000 PHOTOTHERAPY SYSTEMDrager, Inc. · 1995-12-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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