Class 2 Device Recall Imaging systems

• Date Initiated by Firm: January 29, 2019
• Create Date: June 28, 2019
• Recall Status: Open, Classified
• Recall Number: Z-1784-2019
• Recall Event ID: 82988
• Product Classification: Laser target designator - Product Code RET
• Product: TASE 500 Imaging systems
• Code Information: TASE 500
• FEI Number: 3021214229
• Recalling Firm/ Manufacturer: COLLINS AEROSPACE; 9 Technology Park Dr; Westford MA 01886-3141
• Manufacturer Reason for Recall: the Nominal Ocular Hazard Distance (NOHD) associated with a Class lllb alignment laser utilized in its TASE family of imaging systems has been miscalculated.
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Action: Collins Aerospace sent a customer notification letter to affected customers,. The letter identified the affected product problem and actions to be taken. For questions contact Customer Support Team at Support.TASE@collins.com
• Quantity in Commerce: 433 in total
• Distribution: US Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.