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

FDA device recall Z-2411-2012 · posted 2012-09-20 · Terminated

Recall details

Recalling firm

Haag-Streit USA Inc

Reason for recall

The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101.

Action taken

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 : fieldsafetynotice@haag-streit-usa.com. If you have any questions, call 513-336-7255.

Root cause

Equipment maintenance

Status

Terminated

Product code

HPT

Quantity affected

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 Ri

Date initiated

2012-08-17

Date posted

2012-09-20

Date terminated

2015-05-29

Location

Mason, OH