Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000
- Company
- Stryker Communications
- Recall Initiated
- October 11, 2019
- Terminated
- October 18, 2022
- Recall Number
- Z-1602-2020
- Quantity
- 1415 Surgical Lights
- Firm Location
- Flower Mound, TX
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.
Distribution
US: Nationwide OUS: Canada
Lot / Code Info
Serial Number Range: 091316 70016 through 083117-73252
Root Cause
Other
Action Taken
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