FDA Medical Device Recalls (openFDA)
Fisher & Paykel Healthcare Inc: Phototherapy Lamp, Model 9001W501JE
- Recall number
- Z-0241-04
- Recalling firm
- Fisher & Paykel Healthcare Inc
- Product
- Phototherapy Lamp, Model 9001W501JE
- Status
- Terminated
- Initiated
- 2003-12-05
- Posted
- 2003-12-18
- Terminated
- 2005-11-23
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LBI
- Firm FEI
- 3000210616
- Firm city
- Laguna Hills
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28