Mason, OH, United States
Haag-Streit USA Inc recalls
4 recalls recorded since 2018, most recently on 3 November 2021. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)3
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 3 November 2021
- Reason
- Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
- Distribution
- US Nationwide distribution in the states of OH, IN.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0478-2022, Z-0477-2022
- OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
- OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
Ongoing Class II Medical devices
- Recall started
- 15 April 2021
- Reason
- 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
- US Nationwide distribution in the state of WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1560-2021
- Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
Ongoing Class II Medical devices
- Recall started
- 20 November 2020
- Reason
- Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing the button of the footswitch it might occur that the movement does not stop when releasing the button, result in potential risk to the patient's eye
- Distribution
- US Nationwide distribution in the state of OK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0697-2021
- Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. 657 821), with soft
Terminated Class II Medical devices
- Recall started
- 31 July 2019
- Terminated
- 16 April 2020
- Reason
- software error in the central control unit of the floor stand.
- Distribution
- US in the state of OH
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2484-2019, Z-2482-2019, Z-2483-2019
- HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories
- HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. Th
- HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. Th
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.