Severity
Moderate
FDA Devices recall · Reported September 26, 2012
The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101.
Haag-Streit USA Inc recalled Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to… - a moderate-severity action.
Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to… was recalled by Haag-Streit USA Inc in September 26, 2012. Reason: The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimete…. Check the official notice for the remedy. Verify recall #Z-2411-2012 with the FDA Devices before acting.
The recall
Haag-Streit USA Inc issued this moderate-severity FDA Devices recall-The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimete….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2411-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2411-2012) was formally reported on September 26, 2012, with the manufacturer initiating the action on August 17, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Haag-Streit USA Inc is listed as the recalling firm, operating out of Mason, OH. Federal records list the affected scope as 64 units.
The documented reason for this recall is: The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
64 units
Related Recalls
6
3 from same agency
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.
The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2411-2012 |
| Date reported | September 26, 2012 |
| Date initiated | August 17, 2012 |
| Recalling firm | Haag-Streit USA Inc |
| Firm location | Mason, OH |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 26, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.