Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for...

FDA Device Recall #Z-2248-2017 — Class II — April 21, 2017

Recall Summary

Recall Number Z-2248-2017
Classification Class II — Moderate risk
Date Initiated April 21, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Stryker Communications
Location Flower Mound, TX
Product Type Devices
Quantity 57 units

Product Description

Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for local illumination of the patients' body so that illnesses, injuries and disabilities can be diagnosed and treated

Reason for Recall

The exam light may have a tolerance issue with the adapter assembly, which could potentially not allow the snap ring to be seated correctly. If this is the case, there could be insufficient mount force that may cause the equipment to fall, resulting in serious injury.

Distribution Pattern

Worldwide Distribution - US and Canada

Lot / Code Information

Serial Numbers: 7735170-X68377, 7735170-X68397, 7735170-X14846, 7735170-X15688, 7735170-X14492, 7735170-X14495, 7735170-X14497, 7735170-X14501, 7735170-X14502, 7735170-X14504, 7735170-X14506, 7735170-X14507, 7735170-X14508, 7735170-X14510, 7735170-X68383, 7735170-X68384, 7735170-X68385, 7735170-X68386, 7735170-X68393, 7735170-X68394, 7735170-X68395, 7735170-X68396, 7735170-X68392, 7735170-X68400, 7735170-X68401, 7735170-X15607, 7735170-X15608, 7735170-X15609, 7735170-X15610, 7735170-X15611, 7735170-X15612, 7735170-X15613, 7735170-X15614, 7735170-X15615

Other Recalls from Stryker Communications

Recall # Classification Product Date
Z-2620-2025 Class II Chromophare Surgical Light System, REF: CH00000... Jul 15, 2025
Z-1506-2024 Class II Chromophare Surgical Light System , REF CH00000001 Feb 8, 2024
Z-1297-2021 Class II S-Series Equipment Management System; Model Num... Jan 29, 2021
Z-1602-2020 Class II Berchtold Chromophare Ceiling Mounted Surgical ... Oct 11, 2019
Z-2446-2019 Class II Berchtold Chromophare Dual Monitor Carrier Arm ... Aug 1, 2019

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.