Date Initiated by Firm |
August 08, 2008 |
Date Posted |
January 21, 2010 |
Recall Status1 |
Terminated 3 on May 25, 2010 |
Recall Number |
Z-0587-2010 |
Recall Event ID |
54153 |
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Product Classification |
Soft Tissue Dental Laser - Product Code NVK
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Product |
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. |
Code Information |
All SoftLase Pro Dental Lasers. |
Recalling Firm/ Manufacturer |
Zap Lasers LLC 2621 Pleasant Hill Rd Ste B Pleasant Hill CA 94523-2161
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For Additional Information Contact |
925-930-6725
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Manufacturer Reason for Recall |
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.
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FDA Determined Cause 2 |
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 in Commerce |
1375 units |
Distribution |
Worldwide Distribution to 1397 consignees |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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