Z-0556-06

Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers; Manufactured by RH USA, Inc...

Name: Z-0556-06 Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers; Manufactured by RH USA, Inc...
Creator: Lumenis Inc.
Published: 2006-02-09
License: https://open.fda.gov/license/

Lumenis Ltd / initiated 2006-02-09 / Terminated

FDA source

Lumenis Inc. began a recall of Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers; Manufactured by RH USA, Inc., 201 Lindbergh Avenue, Livermore, California 94551 on 2006-02-09. The reason FDA records is "During hair removal treatment, patients' skin can experience burns due to debris accumulating on the sapphire crystal tip". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0556-06
Status: Terminated
Initiated: 2006-02-09
Posted: 2006-02-23
Terminated: 2006-08-28
Recalling firm: Lumenis Ltd
Product: Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers; Manufactured by RH USA, Inc., 201 Lindbergh Avenue, Livermore, California 94551
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: During hair removal treatment, patients' skin can experience burns due to debris accumulating on the sapphire crystal tip.
FDA root cause: Other
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.
Quantity in commerce: 3,426 units
Distribution: The product was released for distribution to 3,426 consignees nationwide. There are 48 international consignees.
Product codes and lots: All codes, All serial numbers

Product code GEX

K003614Class IILightsheer Pulsed Diode Array Laser SystemCoherent Star / cleared 2001-03-13

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)