Haag-Streit USA Inc: Medical Device Recall in 2022 - (Recall #: Z-0477-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4

Product Classification:

Class II

Date Initiated: November 3, 2021

Date Posted: January 19, 2022

Recall Number: Z-0477-2022

Event ID: 89176

Reason for Recall:

Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off

Status: Ongoing

Product Quantity: 2 devices quarantined in US

Code Information:

Serial no. 0005, 0023

Distribution Pattern:

US Nationwide distribution in the states of OH, IN.

Voluntary or Mandated:

Voluntary: Firm initiated