Recall Z-1783-2019— COLLINS AEROSPACE

Name: FDA recall Z-1783-2019
Creator: U.S. Food and Drug Administration
Published: 2019-01-29

Class II · Ongoing

Class II FDA medical device recall by COLLINS AEROSPACE, initiated 2019-01-29. FDA's recall record names no specific 510(k) clearance for this event. Product: TASE 400 Imaging systems. Reason: the Nominal Ocular Hazard Distance (NOHD) associated with a Class lllb alignment laser utilized in its TASE family of imaging systems has been miscalculated..

Recalling firm: COLLINS AEROSPACE
Classification: Class II
Status: Ongoing
Initiated: 2019-01-29
Firm location: Westford, MA, United States

Product description

TASE 400 Imaging systems

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.