FDA Device recall Z-0828-2018
Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000
- FDA Device
- Class II
- terminated
- Published 2018-03-07
On 2018-03-07 the FDA classified a Class II recall of Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000 by Stryker Communications, citing the device could have a missing spanner nut and snap ring which could potentially result in the equipment falling.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0828-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-29 |
| Published | 2018-03-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Communications |
| Distribution | US |
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
The device could have a missing spanner nut and snap ring which could potentially result in the equipment falling.
Identifiers
| code_info | Serial numbers distributed in the U.S.: 022817-71019, 22817-71033, 022817-71034, 022817-71035, 022817-71048, 02281…Serial numbers distributed in the U.S.: 022817-71019, 22817-71033, 022817-71034, 022817-71035, 022817-71048, 022817-71049, 022817-71050, 022817-71051, 030817-71104 030817-71105, 030817-71106, 030817-71107, 030817-71108, 030817-71109, 030817-71110, 030817-71111, 030817-71114, 030817-71115, 030817-71116, 030817-71117, 030817-71120, 030817-71121, 030817-71122, 030817-71123, 030817-71124, 030817-71125, 030817-71126, 030817-71127, 030817-71128, 030817-71129, 030817-71130, 030817-71131, 030817-71132, 30817-71133, 030817-71134, 030817-71135, 030817-71136, 030817-71137, 030817-71139, 030817-71140, 030817-71141, 030817-71142, 030817-71143, 030817-71144, 030817-71145, 030817-71146, 030817-71147, 030817-71148, 030817-71149, 030817-71151, 030817-71152, 030817-71153, 031417 -71180, 031417 71198, 031417-71154, 031417-71155, 031417-71156, 031417-71157, 031417-71158, 031417-71164, 031417-71165, 031417-71166, 031417-71167, 031417-71170, 031417-71171, 031417-71172, 031417-71173, 031417-71174, 0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0828-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.