Octopus 900 Perimeter, EyeSuite Perimetry version i4.000 (Flash v. 2.1.4 & 2.1.5), Model Number: Octopus 900, Distributed by: Haag-Streit USA, Inc., 3535 Kings Mills Rd., Mason, OH 45040 Product Usage: The OCTOPUS 900 Perimeter is designed for the examination, analysis and documentation of the field of sight, especially the light difference sensitivity and other functions of the human eye.
FDA Recall Z-0638-2012 · Posted 2012-01-11
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Recalling FirmHaag-Streit USA Inc
Recall StatusTerminated
Product CodeHJB
Date Initiated2011-11-14
Date Terminated2014-06-26
Product Quantity158 Units
Reason for Recall
Currently there is a possibility, at the start of the perimetry examination, for the background illumination of the cupola not to turn on. If no illumination of cupola occurs, data obtained from the examination could provide the doctor with results that would appear to be better than actual.
Firm Action
Haag-Streit USA Inc sent an Urgent Field Safety Notice letter dated November 11, 2011 to their customers. The letter identified the product, the problem, and the actions to be taken. Customers were instructed to check their unit and if needed upgrade their unit with the new software provided. Customers were advised to complete and return the Software Update Verification Form included. Customers who had distributed the affected product outside of their facility were instructed to immediately notify their customers of the recall.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA and WA and the country of Mexico.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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