| |
Class 2 Device Recall Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel |
 |
| Date Initiated by Firm |
August 01, 2019 |
| Date Posted |
August 30, 2019 |
| Recall Status1 |
Terminated 3 on April 27, 2021 |
| Recall Number |
Z-2446-2019 |
| Recall Event ID |
83510 |
| Product Classification |
Light, surgical, ceiling mounted - Product Code FSY
|
| Product |
Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System. |
| Code Information |
Serial numbers DFP-075-0307-0001 to DFP-075-1014-0230. |
Recalling Firm/
Manufacturer |
Stryker Communications
571 Silveron Blvd
Flower Mound TX 75028
|
| For Additional Information Contact |
Mr. Rick Beutter
469-470-4147
|
Manufacturer Reason
for Recall |
The mounts on the monitor may have an insufficient weld.
|
FDA Determined
Cause 2 |
Process control |
| Action |
The recalling letter issued letters on 8/1/2019 via Fed Ex. |
| Quantity in Commerce |
52 devices |
| Distribution |
Distribution was made to CA, CO, CT, FL, GA, IL, IN, MD, MI, MN, MO, NC, NH, NJ, NY, OH, PA, SC, TN, TX, and WI. There was foreign distribution to Canada and Germany. There was no government/military distribution. |
| 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.
|
|
|
|
