Recall Z-1506-2024— Stryker Communications

Name: FDA recall Z-1506-2024
Creator: U.S. Food and Drug Administration
Published: 2024-02-08

Class II · Ongoing

Class II FDA medical device recall by Stryker Communications, initiated 2024-02-08. It names one FDA 510(k) clearance: K120392. Product: Chromophare Surgical Light System , REF CH00000001. Reason: Due to insufficient mounting force the stability of surgical light system cannot be guaranteed..

Recalling firm: Stryker Communications
Classification: Class II
Status: Ongoing
Initiated: 2024-02-08
Firm location: Flower Mound, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K120392 — CHROMOPHARE F 628 AND F 528Berchtold GmbH & Co. KG·cleared 2012-02-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Chromophare Surgical Light System , REF CH00000001

Reason for recall

Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.

Data sourced from openFDA. This site is unofficial and independent of the FDA.