Recall Z-1691-2019— NeuroLogica Corporation
Class II · Terminated
Class II FDA medical device recall by NeuroLogica Corporation, initiated 2019-05-06, terminated 2020-06-10. It names one FDA 510(k) clearance: K171119. Product: Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. Reason: Potential issue related to the operation of the safety latch within the column that supports the arm due to a possibility of potential bodily harm due to a fall of the arm in an unlikely event that the column wire breaks..
- Recalling firm
- NeuroLogica Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-05-06
- Terminated
- 2020-06-10
- 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 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications
Reason for recall
Potential issue related to the operation of the safety latch within the column that supports the arm due to a possibility of potential bodily harm due to a fall of the arm in an unlikely event that the column wire breaks.
Data sourced from openFDA. This site is unofficial and independent of the FDA.