Drager PT 4000 Phototherapy System
FDA device recall Z-1950-2012 · posted 2012-07-06 · Terminated
Recall details
- Recalling firm
- Draeger Medical Systems, Inc.
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- LBI
- Quantity affected
- 65
- Distribution
- Nationwide Distribution-USA (nationwide) and Puerto Rico.
- Date initiated
- 2012-07-02
- Date posted
- 2012-07-06
- Date terminated
- 2013-07-01
- Location
- Telford, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DRAGER PT4000 PHOTOTHERAPY SYSTEM (K954611) | Drager, Inc. | 1995-12-01 |