FDA Device

Phototherapy Lamp, Model 9001W501JE

Hazard

Component placement presents risk of electrocution to patients.

What You Should Do

Remedy

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.

Products

Phototherapy Lamp, Model 9001W501JE
Brand
Fisher & Paykel Healthcare Inc
UPC
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

Units Affected

88