Z-1506-2024 Class II Ongoing

Recalled by Stryker Communications — Flower Mound, TX

FDA device recall Z-1506-2024 was initiated by Stryker Communications on February 8, 2024 and is designated Class II. Reason for recall: Due to insufficient mounting force the stability of surgical light system cannot be guaranteed. The recall status is ongoing. Affected quantity: 1 unit.

Recall Details

Product Type
Devices
Report Date
April 17, 2024
Initiation Date
February 8, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

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.

Distribution Pattern

US: None OUS: Chili

Code Information

S/N:03857056/ UDI: 07613327296167