Recall Z-1391-2018— NeuroLogica Corporation
Class II · Terminated
Class II FDA medical device recall by NeuroLogica Corporation, initiated 2018-01-12, terminated 2018-08-14. It names one FDA 510(k) clearance: K171085. Product: Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical. Reason: While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit..
- Recalling firm
- NeuroLogica Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-01-12
- Terminated
- 2018-08-14
- 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
Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical
Reason for recall
While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit.
Data sourced from openFDA. This site is unofficial and independent of the FDA.