FDA Device recall Z-1950-2012
Drager PT 4000 Phototherapy System
- FDA Device
- Class II
- terminated
- Published 2012-07-18
On 2012-07-18 the FDA classified a Class II recall of Drager PT 4000 Phototherapy System by Draeger Medical Systems, citing 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 th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1950-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-02 |
| Published | 2012-07-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Draeger Medical Systems |
| Distribution | US |
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
Identifiers
| code_info | Catalog number 2M21700 and serial numbers ASCF-0037 TO ASCF-0061; ASCJ-0037 TO ASCJ-0152; ASCL-0001 TO ASCL-0025; ASCM-…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1950-2012%22
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