Berchtold Chromophare Ceiling Mounted Surgical Light System — Class II medical device recall Z-0828-2018
Terminated recall by Stryker Communications, reported 2018-03-07, distributed nationwide. The device could have a missing spanner nut and snap ring which could potentially result in the equipment fall
| Recall number | Z-0828-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Communications, Flower Mound, TX, United States |
| Recall initiated | 2018-01-29 |
| Classified | 2018-03-01 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2019-07-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,162 devices |
| Model numbers | CH13000000 |
Product
Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000. Product Usage: Chromophare surgical lights are medical lights 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. The Chromophare surgical lights consist of a ceiling tube, SK Box swivel arm support, and a light head. The light head is mounted on a cardanic suspension unit and can be turned, swiveled and tilted in any direction. The spatial repositioning of the light head makes use of the 360 degree rotating swivel/horizontal arm. The 360 degree rotating spring arm is used to adjust the height. The light can be mounted in several configurations, such as a single/dual ceiling mount, a boom-integrated suspension mount, a wall mount, or a mobile roll stand.
Reason for recall
The device could have a missing spanner nut and snap ring which could potentially result in the equipment falling.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.