Z-2411-2012Class II

Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent...

Name: Z-2411-2012 Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent...
Creator: Haag-Streit USA Inc
Published: 2012-08-17
License: https://open.fda.gov/license/

Haag-Streit USA Inc / initiated 2012-08-17 / Terminated / root cause: manufacturing process

FDA source

Haag-Streit USA Inc began a recall of 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... on 2012-08-17. FDA classified it as Class II and gives the reason as "The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2411-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-17
Posted: 2012-09-20
Terminated: 2015-05-29
Recalling firm: Haag-Streit USA Inc
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.
Product code: HPT Perimeter, Automatic, Ac-Powered
Reason for recall: The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101.
Root cause tag: manufacturing process
FDA 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 to : [email protected]. If you have any questions, call 513-336-7255.
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2411-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2411-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20

Product code HPT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)