FDAFDA · Food and drugs·Recall number Z-2411-2012
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.
Published September 26, 2012 · Recall initiated: August 17, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Haag-Streit USA Inc
- Distributor
- Worldwide distribution: USA (nationwide) including states of: AR, CA, CT, FL, GA, IA, IL, LA, MA, MI, MN, MS, NJ, NV, NY, OH, OR, PA, SC, SD, WA, WI, and WV; and to the countries of Jamaica, Puerto Rico, and Mexico.
- Lot
- Model Octopus 101. SN: 119, 136, 165, 166, 221, 222, 225, 236, 243, 273, 277, 279, 370, 371, 392, 507, 541, 553, 570, 602, 603, 611, 620, 622, 661, 667, 668, 687, 690, 726, 741, 744, 794, 796, 1054, 1214, 1275, 1276, 1277, 1313, 1322, 1326, 1380, 1402, 1404, 1413, 1414, 1436, 1437, 1459, 1460, 1489, 1490, 1491, 1492, 1560, 1561, 1607, 1608, 1625, 1626, 1706, 1710, 1852
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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