Recall Z-0828-2018 ยท FSY Light, Surgical, Ceiling Mounted
Stryker Communications
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 equippe
| Date | Mar 1, 2018 (initiated Jan 29, 2018) |
| Status | Terminated |
| Reason | The device could have a missing spanner nut and snap ring which could potentially result in the equipment falling. |
| Root cause | Employee error |
| 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 CommunicationsRA1@stryker.com |
| Quantity | 1,162 devices |
| Distribution | Worldwide Distribution - US Nationwide Distribution and in the countries of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.