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Haag-Streit USA Recalls
9 recalls on record · September 26, 2012 to January 19, 2022 · Medical Devices
Recalls by year
12
17
19
20
21
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 19, 2022Medical DevicesFDA
Haag-Streit USA Inc recalls OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
Hazard: Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
January 19, 2022Medical DevicesFDA
Haag-Streit USA Inc recalls OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
Hazard: Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
May 19, 2021Medical DevicesFDA
Haag-Streit USA Inc recalls Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
Hazard: 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).
December 30, 2020Medical DevicesFDA
Haag-Streit USA Inc recalls Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the opera
Hazard: 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
September 11, 2019Medical DevicesFDA
Haag-Streit USA Inc recalls HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage: A wide range of surgical interventions a
Hazard: software error in the central control unit of the floor stand.
September 11, 2019Medical DevicesFDA
Haag-Streit USA Inc recalls HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wide range of surgical interventions are m
Hazard: software error in the central control unit of the floor stand.
September 11, 2019Medical DevicesFDA
Haag-Streit USA Inc recalls HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A wide range of surgical interventions are m
Hazard: software error in the central control unit of the floor stand.
March 29, 2017Medical DevicesFDA
Haag-Streit USA Inc recalls EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
Hazard: There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.
September 26, 2012Medical DevicesFDA
Haag-Streit USA Inc recalls Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the pe
Hazard: The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101.