Recall Z-0241-04 ยท LBI Unit, Neonatal Phototherapy
Fisher & Paykel Healthcare Inc
Phototherapy Lamp, Model 9001W501JE
| Date | Dec 18, 2003 (initiated Dec 5, 2003) |
| Status | Terminated |
| Reason | Component placement presents risk of electrocution to patients. |
| Root cause | Other |
| Action | A recall letter and a set of instructions for fixing the units was sent to customers with instructions to complete a fax back form to indicate completion of the repair. |
| Quantity | 88 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.