Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1784-2019Class II

TASE 500 Imaging systems

Collins Aerospace / initiated 2019-01-29 / Open, Classified

COLLINS AEROSPACE began a recall of TASE 500 Imaging systems on . FDA classified it as Class II and gives the reason as "the Nominal Ocular Hazard Distance (NOHD) associated with a Class lllb alignment laser utilized in its TASE family of imaging systems has been miscalculated". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-1784-2019
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Collins Aerospace
Product
TASE 500 Imaging systems
Product code
RET Laser Target Designator
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 root 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 [email protected]
Quantity in commerce
433 in total
Distribution
US Nationwide Distribution
Product codes and lots
TASE 500

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1784-2019
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1783-2019Class IIOngoingFDA Mandated
Z-1784-2019Class IIOngoingFDA Mandated