| Date Initiated by Firm | December 05, 2003 |
|---|
| Date Posted | December 18, 2003 |
|---|
| Recall Status1 |
Terminated 3 on November 23, 2005 |
| Recall Number | Z-0241-04 |
|---|
| Recall Event ID |
27875 |
| Product Classification |
Unit, Neonatal Phototherapy - Product Code LBI
|
| Product | Phototherapy Lamp, Model 9001W501JE |
|---|
| Code Information |
The potentially affected lamps have serial numbers within the following ranges: 2000 SN 00501XXxxxxx SN 501XXxxxxx SN 2000-501XXxxxxx 2001 SN 2001-501XXxxxxx SN 01-xx xx xxxxxx 2002 SN 02 xx xx xxxxxx 2003 SN 03 xx xx xxxxxx |
| FEI Number |
3000210616
|
Recalling Firm/
Manufacturer |
Fisher & Paykel Healthcare Inc
22982 Alcalde Drive 101
Laguna Hills CA 92653
|
| For Additional Information Contact | Richard Cookson
949-470-3900 Ext. 327 |
|---|
Manufacturer Reason
for Recall | Component placement presents risk of electrocution to patients. |
|---|
FDA Determined
Cause 2 | 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 in Commerce | 88 |
|---|
| Distribution | Nationwide. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
