FDA Device recall Z-2540-2019
Berchtold Chromophare F628 Surgical Lights
- FDA Device
- Class II
- ongoing
- Published 2019-09-18
On 2019-09-18 the FDA classified a Class II recall of Berchtold Chromophare F628 Surgical Lights by Stryker Communications, citing the back cover of the light head was insufficiently assembled and could potentially fall off the light.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2540-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-03-22 |
| Published | 2019-09-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Stryker Communications |
| Distribution | US |
Product
Berchtold Chromophare F628 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations.
Reason
The back cover of the light head was insufficiently assembled and could potentially fall off the light.
Identifiers
| code_info | Serial number ranges: 83171-0017818 to 83171-0123938 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2540-2019%22
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