Device recall
Z-0697-2021: Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no…
FDA device recall · Class II · Haag-Streit USA Inc
Key facts
| Recall number (Z-number) | Z-0697-2021 |
|---|---|
| Recall event | 86707 |
| 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… |
| Product code | HRM |
| Recalling firm | Haag-Streit USA Inc |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1000136533 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database