The Recall Desk
HighFDA (Devices)·Z-0478-2022·Announced 2022-01-19

OCT Camera Laser Safety Shut-Off Malfunction Affects Three Units

Haag-Streit USA is recalling OCT-Camera 211 01 A3 units due to malfunction of the automatic laser beam shut-off. The device may not correctly recognize when the laser beam is safely switched off.

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 an FDA Class II recall of a medical device with a malfunction in a critical safety mechanism (laser shut-off). No injuries or illnesses have been reported. The hazard represents a potential risk of harm rather than actualized harm, which per the rubric qualifies as High (Score 3).

Plain-English summary

Haag-Streit USA Inc is recalling the OCT-Camera 211 01 A3 running iOCT-Control 3 v1.4 software due to a malfunction in its automatic laser beam shut-off mechanism. Three units with serial numbers 0157, 0158, and 0171 are affected. The units were distributed in Ohio and Indiana.

The device may not correctly recognize whether the laser beam is safely switched off. This malfunction could result in unintended laser exposure.

Users of affected serial numbers should contact Haag-Streit USA Inc for corrective action guidance.

The recalled product

Product
OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
Manufacturer
Haag-Streit USA Inc
Category
Medical Device — Optical Imaging
Hazard
  • laser-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. 0157
  • 0158 & 0171

Distribution

Distributed nationwide across the United States.

Related recalls

Same category