Recall Z-2539-2019— Stryker Communications
Class II · Ongoing
Class II FDA medical device recall by Stryker Communications, initiated 2019-03-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations.. Reason: The back cover of the light head was insufficiently assembled and could potentially fall off the light..
- Recalling firm
- Stryker Communications
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-03-22
- Firm location
- Flower Mound, TX, United States
Product description
Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations.
Reason for recall
The back cover of the light head was insufficiently assembled and could potentially fall off the light.
Data sourced from openFDA. This site is unofficial and independent of the FDA.