Home / Recalls / Haag-Streit USA Inc / Z-1560-2021

Z-1560-2021 Class II Ongoing

Recalled by Haag-Streit USA Inc — Mason, OH

Recall Details

Product Type
Devices
Report Date
May 19, 2021
Initiation Date
April 15, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.

Reason for Recall

Examination data and patient name may be mixed up when printing or generating a pdf with the interface at Pacific Coast and Laser Institute (PCLI).

Distribution Pattern

US Nationwide distribution in the state of WA.

Code Information

Software version 9.3.1

Other recalls by Haag-Streit USA Inc

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  • 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-2484-2019 Class II — HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage: (July 31, 2019)
  • 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-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)