—#169470

Product

Discovery NM/CT 670 ES, model 5376204-70-57

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K093514
Affected lot / code info: GTIN 00840682123877 Serial Numbers: ESDX35013, ESDW35010

Why it was recalled

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.

Root cause (FDA determination)

Component change control

Action the firm took

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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: CA, DC, OH, UT, WI, Canada

Timeline

Recall initiated: 2018-05-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #169470. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.