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Terminated

Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers; Manufactured by RH USA, Inc., 201 Lindbergh Avenue, Livermore, California 94551

FDA Recall Z-0556-06 · Posted 2006-02-23

Recalling FirmLumenis Inc.
Recall StatusTerminated
Product CodeGEX
Date Initiated2006-02-09
Date Terminated2006-08-28
Product Quantity3,426 units

Reason for Recall

During hair removal treatment, patients' skin can experience burns due to debris accumulating on the sapphire crystal tip.

Firm Action

On 2/9/06, the firm initiated the recall and its notification was via letters informing its customers of the corrective action. In May 2005, Lumenis mailed a 'Dear Doctor' letter to LightSheer Diode Laser System customers describing more detailed cleaning procedures to be used on the sapphire tips due to skin burns patients' were experiencing from debris build-up on the tip.

Root Cause

Other

Distribution Pattern

The product was released for distribution to 3,426 consignees nationwide. There are 48 international consignees.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K003614LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEMCoherent Star · 2001-03-13

Official Source

View FDA Recall →

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

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