Events

Recall of Device Recall Octopus 900

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Haag-Streit USA Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60631
  • Event Risk Class
    Class 2
  • Event Number
    Z-0638-2012
  • Event Initiated Date
    2011-11-14
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106088
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Instrument, measuring, corneal radius - Product Code HJB
  • Reason
    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.
  • 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.

Device

Device Recall Octopus 900
  • Model / Serial
    Model Number: Octopus 900, S/N's: 159, 231, 279, 313, 314, 315, 336, 338, 478, 479, 484, 485, 559, 560,561, 562, 563, 642, 644, 645, 646, 647, 648, 649, 650, 651, 772, 773, 774, 775, 776, 777, 797, 798, 804, 805, 806, 807, 808, 813, 814, 839, 840, 841, 842, 843, 844, 868, 869, 870, 871, 872, 873, 874, 903, 904, 905, 907, 908, 909, 910, 911, 956, 957, 958, 959, 975, 983, 984, 985, 986, 987, 1002, 1003, 1004, 1005, 1006, 1007, 1008, 1034, 1035, 1036, 1037, 1038, 1059, 1060, 1061, 1062, 1063, 1064, 1065, 1066, 1117, 1118, 1119, 1120, 1140, 1141, 1143, 1152, 1162, 1163, 1164, 1166, 1199, 1200, 1201, 1202, 1239, 1240, 1241, 1262, 1263, 1286, 1287, 1288, 1307, 1308, 1401, 1402, 1403, 1404, 1405, 1424, 1425, 1426, 1458, 1459, 1460, 1480, 1481, 1482, 1483, 1484, 1543, 1545, 1546, 1550, 1552, 1553, 1554, 1555, 1556, 1560, 1561, 1562, 1563, 1564, 1579, 1580, 1581, 1582, 1583, 1586, 1587, 1588, 1589 and 1591.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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.
  • Manufacturer
    Haag-Streit USA Inc

Manufacturer

Haag-Streit USA Inc
  • Manufacturer Address
    Haag-Streit USA Inc, 3535 Kings Mills Rd, Mason OH 45040
  • Manufacturer Parent Company (2017)
    Metall Zug Ag
  • Source
    USFDA