Recall Z-2411-2012— Haag-Streit USA Inc
Class II · Terminated
Class II FDA medical device recall by Haag-Streit USA Inc, initiated 2012-08-17, terminated 2015-05-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.. Reason: The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101..
- Recalling firm
- Haag-Streit USA Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-17
- Terminated
- 2015-05-29
- Firm location
- Mason, OH, United States
Product description
Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.
Reason for recall
The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101.
Data sourced from openFDA. This site is unofficial and independent of the FDA.