FDA Recall Completed

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.

Recall: Z-0606-2019 · Initiated May 24, 2018

Recall

Recall Number
Z-0606-2019
Event Number
81680
Firm
GE Healthcare, LLC
FEI Number
2126677
Product Code
KPS
Status
Completed
Root Cause
Component change control
Initiated
May 24, 2018
Address
3000 N Grandview Blvd, Waukesha, WI, 53188-1615

Description

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.

Reason

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.

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.

Distribution

CA, DC, OH, UT, WI, Canada

Quantity

4 units