Date Initiated by Firm |
February 08, 2024 |
Date Posted |
April 09, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1506-2024 |
Recall Event ID |
94199 |
510(K)Number |
K120392
|
Product Classification |
Light, surgical, ceiling mounted - Product Code FSY
|
Product |
Chromophare Surgical Light System , REF CH00000001 |
Code Information |
S/N:03857056/ UDI: 07613327296167 |
Recalling Firm/ Manufacturer |
Stryker Communications 571 Silveron Blvd Flower Mound TX 75028
|
For Additional Information Contact |
Ashley Lower 972-410-7100
|
Manufacturer Reason for Recall |
Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.
|
FDA Determined Cause 2 |
Employee error |
Action |
On February 19, 2024, Stryker issued a Urgent Medical Device Recall notification via XXX. In addition to notifying consignees about the recall. Stryker asked consignees to take the following actions:
Inform individuals within your organization who need to be aware of this action.
2. Check your internal inventory to locate the product listed in the product affected grid. If affected product is found,
segregate and do not use the product.
3. Complete and sign the enclosed Business Reply Form on Attachment A and return to
CommunicationsRA1@stryker.com.
4. A Sales Representative or Field Service Technician will be in contact with your facility to schedule a service visit to
perform the recall activities.
5. Maintain awareness of this communication internally until all required actions have been completed within your
facility. Response is required. |
Quantity in Commerce |
1 unit |
Distribution |
US: None
OUS: Chili |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database |
510(K)s with Product Code = FSY and Original Applicant = BERCHTOLD GMBH & CO. KG
|