Recall Z-2411-2012 ยท HPT Perimeter, Automatic, Ac-Powered
Haag-Streit USA Inc
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.
| Date | Sep 20, 2012 (initiated Aug 17, 2012) |
| Status | Terminated |
| Reason | The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101. |
| Root cause | Equipment maintenance |
| Action | The firm, HAAG-STREIT USA, Inc., sent a "Field Safety Notice 2012-01/01" dated August 10, 2012 via certified mail or onsite visit to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to make all users of the product and relevant personnel aware of this Field Safety Notice; forward a copy to third parties, if affected product has been passed on; keep this notice at least until the completion of the corrective measure, and complete and return the enclosed Confirmation of Receipt Form via fax to: 513-229-3867 or scanned and emailed t |
| Quantity | 64 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.