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FDA (Device enforcement)Recalled 2018-05-24class ii

GE Healthcare, LLC: Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormaliti

Is my product affected?

Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.

  • UPC 00840682124393

Check against the official notice below — it lists the full affected range.

What happened

GE Healthcare, LLC has recalled the Discovery NM/CT 670 DR model 5376204-70-56, a medical imaging system used to detect, localize, and diagnose diseases and evaluate organ function. The recall affects four units distributed in California, Delaware, Ohio, Utah, Wisconsin, and Canada. The specific serial numbers involved are DDRW34032, DDRX34038, DDRX34041, and DDRX34045.

The hazard involves improper wiring of the Main disconnect switch, EPO (Emergency Power Off) button on the A1 panel, and Remote EPO buttons that may be located outside the A1 panel. Due to this wiring defect, these switches and buttons may not shut off all power to the system as intended, creating a potential electrical hazard. The source document does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Distribution: CA, DC, OH, UT, WI, Canada Quantity: 4 units Lot/code info: GTIN 00840682124393 Serial Numbers: DDRW34032, DDRX34038, DDRX34041, DDRX34045

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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