Drager PT 4000 Phototherapy System — Class II medical device recall Z-1950-2012
Terminated recall by Draeger Medical Systems, Inc., reported 2012-07-18, distributed nationwide. A routine internal quality check found that the Drager PT 4000 Phototherapy System is fitted with a 16 Amp rat
| Recall number | Z-1950-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger Medical Systems, Inc., Telford, PA, United States |
| Recall initiated | 2012-07-02 |
| Classified | 2012-07-06 |
| Reported by FDA | 2012-07-18 |
| Terminated | 2013-07-01 |
| Distributed | Nationwide (US) |
| Quantity | 65 |
| Reason classes | device malfunction |
| Serial numbers | 0005, 0006, 0007, 0008, 0009, 0012, 0019, 0025, ASCF-0037, ASCF-0061, ASCJ-0037, ASCJ-0152, ASCL-0001, ASCL-0025, ASCM-0001, ASCM-0025, ASDA-002 |
| Model numbers | 2M21700 |
Product
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.