Recall Z-0116-2007 ยท HJN Transilluminator, Battery-Powered
Venoscope LLC
Venoscope Neonatal Transilluminator, Model NT01
| Date | Oct 28, 2006 (initiated Apr 28, 2005) |
| Status | Terminated |
| Reason | Excessive heating due to incorrect wire assembly process. |
| Root cause | Other |
| Action | The firm notified its consignees about the problem beginning on 04/28/2006 and requested the consignee (nurses and distributors) open the battery compartment and check for the absence of an identifying mark (there are no exterior lot numbers). The recalling firm requested the return of all lights which had no identifying marks inside the battery compartment. |
| Quantity | 118 distributed |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.