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.
FDA Recall Z-0828-2018 · Posted 2018-03-01
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Recalling FirmStryker Communications
Recall StatusTerminated
Product CodeFSY
Date Initiated2018-01-29
Date Terminated2019-07-08
Product Quantity1,162 devices
Reason for Recall
The device could have a missing spanner nut and snap ring which could potentially result in the equipment falling.
Firm Action
Stryker sent an Urgent Medical Device Correction letters to affected customers. The letter identified the affected product, problem and actions to be taken. The customer is informed a firm representative will be conducting a visual inspection of the equipment. No response form was enclosed. For questions email [email protected]
Root Cause
Employee error
Distribution Pattern
Worldwide Distribution - US Nationwide Distribution and in the countries of Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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