Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1784-2019 — TASE 500 Imaging systems

U.S. FDA — Device Enforcement · United States · 2019-01-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1784-2019
Date of alert
2019-01-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
COLLINS AEROSPACE
Product category
device
Product type
Devices
Reported risk: the Nominal Ocular Hazard Distance (NOHD) associated with a Class lllb alignment laser utilized in its TASE family of imaging systems has been miscalculated.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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