Recall Z-2715-2024— NeuroLogica Corporation
Class II · Ongoing
Class II FDA medical device recall by NeuroLogica Corporation, initiated 2024-07-08. It names one FDA 510(k) clearance: K150097. Product: GM60A. Digital Diagnostic Mobile X-Ray System.. Reason: Potential for the anti-fall system of the device arm to fail..
- Recalling firm
- NeuroLogica Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-07-08
- Firm location
- Danvers, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
GM60A. Digital Diagnostic Mobile X-Ray System.
Reason for recall
Potential for the anti-fall system of the device arm to fail.
Data sourced from openFDA. This site is unofficial and independent of the FDA.