FDAFDA · Food and drugs·Recall number Z-1783-2019
TASE 400 Imaging systems
Published July 3, 2019 · Recall initiated: January 29, 2019
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
the Nominal Ocular Hazard Distance (NOHD) associated with a Class lllb alignment laser utilized in its TASE family of imaging systems has been miscalculated.
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- COLLINS AEROSPACE
- Distributor
- US Nationwide Distribution
- Lot
- TASE 400
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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