Recall Z-1414-2023— NeuroLogica Corporation
Class II · Ongoing
Class II FDA medical device recall by NeuroLogica Corporation, initiated 2023-03-08. It names one FDA 510(k) clearance: K222353. Product: Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System. Reason: Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm due to a fall of the arm.
- Recalling firm
- NeuroLogica Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-03-08
- 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
Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System
Reason for recall
Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm due to a fall of the arm
Data sourced from openFDA. This site is unofficial and independent of the FDA.