FDA Medical Device Recalls (openFDA)
NeuroLogica Corporation: Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical
- Recall number
- Z-1391-2018
- Recalling firm
- NeuroLogica Corporation
- Product
- Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical
- Status
- Terminated
- Initiated
- 2018-01-12
- Posted
- not on file
- Terminated
- 2018-08-14
- 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.
- Root cause
- Device Design
- Action
- A field safety notice was sent stating that the manufacturer, without charge, will remedy the defect. The notice stated that field upgrades would be performed by December 31, 2017. The notice provided instructions to end users and to distributors. For further questions, please call (978) 564-8503.
- Quantity
- 16 units
- Distribution
- US Distribution . Only one consignee was shipped 16 units of the affected device.
- Lot, serial or model codes
- Model Number GMR40. Serial numbers 00001 through 00016.
- 510(k) numbers
- ["K171085"]
- PMA numbers
- not on file
- Product code
- MQB
- Firm FEI
- 3004938766
- Firm city
- Danvers
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28