Enforcement Report - Week of July 18, 2012
-
Back to Previous Page
Event Detail
| Event ID | 62470 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Draeger Medical Systems, Inc. |
| City | Telford |
| State | PA |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-02 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution-USA (nationwide) and Puerto Rico. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Drager PT 4000 Phototherapy System | 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. | Class II | 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 been any reports received from the field of such cases occurring, or any injury or harm being suffered in connection with this issue. | 65 | Z-1950-2012 |
-
