Recall Z-0480-2026— NeuroLogica Corporation

Name: FDA recall Z-0480-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-07

Class II · Ongoing

Class II FDA medical device recall by NeuroLogica Corporation, initiated 2025-10-07. It names one FDA 510(k) clearance: K222353. Product: GM85 Digital Mobile X-ray imaging System; Model Number: GM85;. Reason: The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue..

Recalling firm: NeuroLogica Corporation
Classification: Class II
Status: Ongoing
Initiated: 2025-10-07
Firm location: Danvers, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K222353 — GM85Samsung Electronics Co., Ltd.·cleared 2022-09-29

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

GM85 Digital Mobile X-ray imaging System; Model Number: GM85;

Reason for recall

The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.

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