Stryker Communications: Chromophare Surgical Light System Recalled for Mounting Force Defect

Agency Publication Date: April 9, 2024

Summary

Stryker Communications has recalled one unit of the Chromophare Surgical Light System (Model REF CH00000001) because the system lacks sufficient mounting force. This defect means the stability of the surgical light system cannot be guaranteed during medical procedures. The affected unit, serial number 03857056, was manufactured in the United States and distributed to Chile. Consumers should contact the manufacturer immediately to ensure the device is safely secured or serviced.

Risk

Insufficient mounting force can cause the surgical light system to become unstable or shift unexpectedly. This poses a risk of the heavy equipment falling or moving during surgery, which could cause physical injury to patients or medical staff.

What You Should Do

Identify if you have the affected Chromophare Surgical Light System by checking the reference number REF CH00000001 and Serial Number (S/N) 03857056.
Verify the Unique Device Identifier (UDI) on the product labeling matches 07613327296167.
Contact Stryker Communications at their Flower Mound, Texas facility or through your local representative to arrange for an inspection and to ensure the mounting force is corrected.
If you are a healthcare provider using this device, contact your medical facility's engineering or maintenance department to report the stability concern.
For additional information or questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer correction/service

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Chromophare Surgical Light System

Model / REF:

REF CH00000001

UPC Codes:

07613327296167

Lot Numbers:

S/N:03857056

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94199

Status: Active

Manufacturer: Stryker Communications

Sold By: Stryker Communications

Manufactured In: United States

Units Affected: 1 unit

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the affected Chromophare Surgical Light System by checking the reference number REF CH00000001 and Serial Number (S/N) 03857056.

Verify the Unique Device Identifier (UDI) on the product labeling matches 07613327296167.

Contact Stryker Communications at their Flower Mound, Texas facility or through your local representative to arrange for an inspection and to ensure the mounting force is corrected.

If you are a healthcare provider using this device, contact your medical facility's engineering or maintenance department to report the stability concern.

For additional information or questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.