Recall Z-1056-2024— NeuroLogica Corporation
Class II · Ongoing
Class II FDA medical device recall by NeuroLogica Corporation, initiated 2023-12-28. It names one FDA 510(k) clearance: K222353. Product: Samsung Digital Diagnostic Mobile X-ray System, Model GM85.. Reason: Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm..
- Recalling firm
- NeuroLogica Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-12-28
- 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
Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
Reason for recall
Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm.
Data sourced from openFDA. This site is unofficial and independent of the FDA.