Z-0241-04

Phototherapy Lamp, Model 9001W501JE

Name: Z-0241-04 Phototherapy Lamp, Model 9001W501JE
Creator: Fisher & Paykel Healthcare Inc
Published: 2003-12-05
License: https://open.fda.gov/license/

Fisher & Paykel Healthcare, Inc. / initiated 2003-12-05 / Terminated

FDA source

Fisher & Paykel Healthcare Inc began a recall of Phototherapy Lamp, Model 9001W501JE on 2003-12-05. The reason FDA records is "Component placement presents risk of electrocution to patients". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0241-04
Status: Terminated
Initiated: 2003-12-05
Posted: 2003-12-18
Terminated: 2005-11-23
Recalling firm: Fisher & Paykel Healthcare, Inc.
Product: Phototherapy Lamp, Model 9001W501JE
Product code: LBI Unit, Neonatal Phototherapy
Reason for recall: Component placement presents risk of electrocution to patients.
FDA 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 in commerce: 88
Distribution: Nationwide.
Product codes and lots: 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

Product code LBI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)