Recall Z-1950-2012 ยท LBI Unit, Neonatal Phototherapy
Draeger Medical Systems, Inc.
Drager PT 4000 Phototherapy System
| Date | Jul 6, 2012 (initiated Jul 2, 2012) |
| Status | Terminated |
| 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 |
| Root cause | Other |
| 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. |
| Quantity | 65 |
| Distribution | Nationwide Distribution-USA (nationwide) and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K954611 | DRAGER PT4000 PHOTOTHERAPY SYSTEM Drager, Inc., Dec 1, 1995 |