Company: Haag-Streit USA Inc
Date of Enforcement Report: 12/30/2020
Class II

PRODUCT

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 software REF 615 588 versions 2.0 to 3.3 – Product Usage: use in ophthalmology and in other disciplines with vertical direction of view.

Recall Number: Z-0697-2021

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.

RECALLING FIRM/MANUFACTURER

Haag-Streit USA Inc on 11/20/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

3 units US

DISTRIBUTION

U.S. Nationwide