Recall Z-2484-2019 ยท EPT Microscope, Surgical
Haag-Streit USA Inc
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. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS Hi-R NEO 900A NIR and HS ALLEGRA 900/590/90 are designed for use in Ophthalmology and in other disciplines where a vertica
| Date | Jul 31, 2019 |
| Status | Terminated |
| Reason | software error in the central control unit of the floor stand. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | 1. Do not perform any other functions at the same time when operation the XY control, such as changes in the light intensity. 2. Perform a software update of the floor stand. you will receive the software version 11.4 through your local representative which will fix the bug. 3. please send us the enclosed response form filled In as soon as possible. 4. If you have passed the products to third parties, please forward a copy of this information and inform the below mentioned contact person. The software update will be organized through Haag-Streit USA. For questions concerning this procedu |
| Quantity | 1 |
| Distribution | US in the state of OH |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.