Home / Recalls / Haag-Streit USA Inc / Z-0477-2022

Z-0477-2022 Class II Ongoing

Recalled by Haag-Streit USA Inc — Mason, OH

Recall Details

Product Type
Devices
Report Date
January 19, 2022
Initiation Date
November 3, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 devices quarantined in US

Product Description

OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4

Reason for Recall

Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off

Distribution Pattern

US Nationwide distribution in the states of OH, IN.

Code Information

Serial no. 0005, 0023

Other recalls by Haag-Streit USA Inc

  • Z-0478-2022 Class II — OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4 (November 3, 2021)
  • Z-1560-2021 Class II — Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscop (April 15, 2021)
  • Z-0697-2021 Class II — Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. (November 20, 2020)
  • Z-2482-2019 Class II — HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A wi (July 31, 2019)
  • Z-2483-2019 Class II — HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wi (July 31, 2019)
  • Z-2484-2019 Class II — HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage: (July 31, 2019)
  • Z-1500-2017 Class II — EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocul (January 5, 2017)
  • Z-2411-2012 Class II — Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device in (August 17, 2012)