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U.S. Department of Health and Human Services

Class 2 Device Recall Berchtold Chromophare Ceiling Mounted Surgical Light System

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  Class 2 Device Recall Berchtold Chromophare Ceiling Mounted Surgical Light System see related information
Date Initiated by Firm October 11, 2019
Create Date March 27, 2020
Recall Status1 Terminated 3 on October 18, 2022
Recall Number Z-1602-2020
Recall Event ID 85083
Product Classification Light, surgical, ceiling mounted - Product Code FSY
Product Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000
Code Information Serial Number Range: 091316 70016 through 083117-73252
Recalling Firm/
Manufacturer		 Stryker Communications
571 Silveron Blvd
Flower Mound TX 75028
For Additional Information Contact Rick Beutter
469-470-4147
Manufacturer Reason
for Recall		 The firm has become aware that there is a likelihood that a missing snap ring or spanner nut may result in an insufficient mount force that causes the surgical light to fall. If the suspension of the surgical light falls, it may potentially cause serious injuries to Health Care Providers and/or patients.
FDA Determined
Cause 2		 Other
Action On October 11, 2019, a "Urgent Medical Device Correction" letter was sent to all affected customers via FedEx. In addition to explaining the recall, the recall letter as customers to take the following action: Please assure this notification letter is disseminated within your organization. A Stryker Representative will begin scheduling visits to customer facilities to perform inspections. This correction is expected to last one year. During the inspection, the Stryker Representative will perform a visual inspection on the lower portion of the Chromophare Ceiling Mounted Surgical Light Suspension. If a nonconforming unit is found, Stryker will replace the non-conforming Chromophare Ceiling Mounted Surgical Light Suspension with a new Chromophare Ceiling Mounted Surgical Light Suspension. In the meantime, the lights can continue to remain in full use. If you have any questions or notice any issues regarding this correction: " Stryker Technical Support at 866-841-5663 or comm.techservices@stryker.com " Nicole Kubat, Senior RA Compliance Specialist at 469-470-4318 or Nicole.Kubat@stryker.com " E-mail: CommunicationsRA1@stryker.com
Quantity in Commerce 1415 Surgical Lights
Distribution US: Nationwide OUS: Canada
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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