Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000. Product Usage: Chromophare surgical li
FDA device recall Z-0828-2018 · posted 2018-03-01 · Terminated
Recall details
- Recalling firm
- Stryker Communications
- Reason for recall
- The device could have a missing spanner nut and snap ring which could potentially result in the equipment falling.
- Action taken
- 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
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FSY
- Quantity affected
- 1,162 devices
- Distribution
- Worldwide Distribution - US Nationwide Distribution and in the countries of Canada.
- Date initiated
- 2018-01-29
- Date posted
- 2018-03-01
- Date terminated
- 2019-07-08
- Location
- Flower Mound, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.