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Terminated

Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical

FDA Recall Z-1391-2018 · Posted None

Recalling FirmNeuroLogica Corporation
Recall StatusTerminated
Product CodeMQB
Date Initiated2018-01-12
Date Terminated2018-08-14
Product Quantity16 units

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

US Distribution . Only one consignee was shipped 16 units of the affected device.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K171085GMR40Neurologica Corporation, A Subsidiary OF · 2017-05-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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