Collins Aerospace TASE 400 Imaging Systems Recalled for Laser Safety Error
Collins Aerospace is recalling 433 TASE 400 Imaging systems because the Nominal Ocular Hazard Distance for the alignment laser was miscalculated.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a Class IIIB laser with a miscalculated safety distance, representing a risk of harm (laser exposure) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Collins Aerospace is recalling 433 TASE 400 Imaging systems distributed nationwide in the United States. The recall is due to a miscalculation of the Nominal Ocular Hazard Distance (NOHD) associated with the Class IIIB alignment laser utilized in the TASE family of imaging systems.
The miscalculation of the NOHD means the safe distance from the laser may be incorrect, potentially exposing users to laser radiation beyond the intended safe limits. The source text does not specify if any injuries or illnesses have been reported as a result of this defect.
Users of the TASE 400 Imaging systems should stop using the equipment and contact Collins Aerospace for instructions on how to proceed with the recall.
The recalled product
- Product
- TASE 400 Imaging systems
- Manufacturer
- COLLINS AEROSPACE
- Category
- Medical Device — Imaging Systems
- Hazard
- Affected units
- 433
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- TASE 400
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by COLLINS AEROSPACE under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · COLLINS AEROSPACE
See all →- HighCollins Aerospace TASE 500 Imaging Systems Recalled for Laser Safety Error
FDA (Devices) · 2019-07-03
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