FDAFDA · Food and drugs·Recall number Z-0348-2014
Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser GentleLase Pro LE, Model number: 9914-00-9040
Published November 27, 2013 · Recall initiated: November 6, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Candela Corporation
- Distributor
- Worldwide distribution: US (nationwide) and Internationally to: Azerbaijan, Bulgaria, Chile, Czech Republic, Greece, Israel, Kuwait, Qatar, Saudi Arabia, Serbia, Turkey, and the United Arab Emirates and to Subsidiaries in Australia, France, Germany, Italy, Japan, Portugal, Spain, and the United Kingdom.
- Lot
- GL Pro Model 9914-00-9015:: SN 9914-9015-0005 through 9914-9015-1259 GL Pro LE Model 9914-00-9040: SN 9914-9040-0716 through 9914-9040-1214
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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