Recall Z-0697-2021 ยท HRM Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
Haag-Streit USA Inc
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
| Date | Nov 20, 2020 |
| Status | Open, Classified |
| 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 |
| Root cause | Software design |
| Action | Haag-Streit USA, Inc. notified accounts by Urgent Medical Device Correction letter via UPS on 11/20 and delivered 11/24, stating reason for recall, health risk, and action to take: Since the error only occurs when using the optional microscope accessory EIBOS 2, we recommend the following action: 1. Operate the focusing only as described in the instructions for use 668 600 part 5.4 when the fundus observation module EIBOS 2 is swiveled in (see following extract from the above-mentioned Instructions for Use). 5.4 During Surgery Surgery starts at the anterior segment of the eye. The operating m |
| Quantity | 3 units US |
| Distribution | US Nationwide distribution in the state of OK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.