Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
Recall
- Recall Number
- Z-2620-2025
- Event Number
- 97285
- Firm
- Stryker Communications
- FEI Number
- 3002975342
- Product Code
- FSY
- Status
- Open, Classified
- Root Cause
- Component change control
- Initiated
- July 15, 2025
- Posted
- September 24, 2025
- Address
- 571 Silveron Blvd, Flower Mound, TX, 75028
Description
Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.
On 7/15/2025, recall notices were mailed or hand delivered to customers who were asked to do the following: Inform individuals within your organization who need to be aware of this action. 2. A Stryker representative will be in contact with your account to schedule a field service visit at your earliest convenience to complete the following: a. Deinstall impacted Oculan light(s) and reinstall with SLX lights to ensure your operating room stays in use. b. Upon product remediation and availability, Stryker will return to reinstall Oculan within your operating room(s). Your local Stryker representative will provide timing updates as they are available. 3. Complete and return the Business Reply Form to [email protected] 4. Maintain awareness of this communication internally until all required actions have been completed within your facility.
US Nationwide distribution in the states of TX, IL, NY, UT, OR, AZ, VT, NY, IL, MN.
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