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Terminated

Phototherapy Lamp, Model 9001W501JE

FDA Recall Z-0241-04 · Posted 2003-12-18

Recalling FirmFisher & Paykel Healthcare Inc
Recall StatusTerminated
Product CodeLBI
Date Initiated2003-12-05
Date Terminated2005-11-23
Product Quantity88

Reason for Recall

Component placement presents risk of electrocution to patients.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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