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Completed

Discovery NM/CT 670 Pro, model 5376204-70-54

FDA Recall Z-0608-2019 · Posted None

Recalling FirmGE Healthcare, LLC
Recall StatusCompleted
Product CodeKPS
Date Initiated2018-05-24
Product Quantity1 unit

Reason for Recall

When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could result in these not shutting off all power to the entire system as intended, resulting in a potential electric hazard.

Firm Action

The firm initiated the recall by letter on 05/24/2018. The letter explained the issue and requested the UPS(s) be disconnected from the system until the system could be repaired.

Root Cause

Component change control

Distribution Pattern

CA, DC, OH, UT, WI, Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093514DISCOVERY MODEL NM/CT 670Ge Medical Systems F.I. Haifa · 2009-12-10

Official Source

View FDA Recall →

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

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