The Recall Desk
HighFDA (Devices)·Z-0477-2022·Announced 2022-01-19

OCT-Camera Laser Shut-Off Malfunction Poses Patient Safety Risk

Haag-Streit OCT-Camera devices with automatic laser shut-off malfunction may fail to recognize when the laser is safely switched off, posing a potential safety risk.

What this means for you

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: This is a Class II recall of a medical device with a safety-critical malfunction: the automatic laser beam shut-off may fail to function properly. While no injuries have been reported, the hazard poses a direct risk of harm from uncontrolled laser operation.

Plain-English summary

Haag-Streit USA Inc is recalling OCT-Camera 211 01 A1 devices running iOCT-Control 3 v1.4 software. Two devices have been quarantined in the United States (serial numbers 0005 and 0023).

The automatic laser beam shut-off feature may malfunction, and the device may not properly recognize whether the laser beam is safely switched off. This creates a potential risk of continued laser operation when the beam should be disabled.

The affected devices were distributed nationwide in Ohio and Indiana. This is a Class II recall issued by the U.S. Food and Drug Administration.

The recalled product

Product
OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
Manufacturer
Haag-Streit USA Inc
Category
Medical Device — Diagnostic Imaging
Hazard
  • laser-safety
  • control-malfunction

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 (2)

  • Serial no. 0005
  • 0023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category