Recall Z-1950-2012— Draeger Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Draeger Medical Systems, Inc., initiated 2012-07-02, terminated 2013-07-01. It names one FDA 510(k) clearance: K954611. Product: Drager PT 4000 Phototherapy System. 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.
- Recalling firm
- Draeger Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-07-02
- Terminated
- 2013-07-01
- Firm location
- Telford, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Drager PT 4000 Phototherapy System
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
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