Recall Z-0587-2010 ยท NVK Laser, Dental, Soft Tissue
Zap Lasers LLC
SoftLase Pro Dental Lasers: Zap SoftLase, SoftLase Pro, OrthoLase, and HygieneLase models, Model numbers ZA-SLP, ZA-ORT, ZA-HYG, G22002SLP, ZA-SOFTLASE2WSII, ZA-SOFTLASER2W, Manufactured by Zap Lasers LLC, Pleasant Hill, CA. Intended use: Dentistry.
| Date | Jan 21, 2010 (initiated Aug 8, 2008) |
| Status | Terminated |
| Reason | The SoftLase Lasers are in need of compliance upgrades due to lack of a remote interlock connector, an emission delay, user guide labels and locations, and calibration procedures and schedule. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Zap Lasers sent a letter to affectedcustomers stating that their SoftLase diode laser is eligible for a compliance maintenance upgrade. The upgrades will be free of charge and will enhance the safety of the laser. Customers are encouraged to call the firm's customer service line at 888-876-4547 to schedule their RMA number and shipping instructions. The letter also lists the upgrades that are needed. |
| Quantity | 1375 units |
| Distribution | Worldwide Distribution to 1397 consignees |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.