The Recall Desk
SevereFDA (Devices)·Z-0606-2019·Announced 2018-12-19

GE Healthcare Recalls Discovery NM/CT 670 DR Due to Electrical Hazard

GE Healthcare is recalling four Discovery NM/CT 670 DR units because incorrect wiring of safety switches may prevent the system from shutting off power, creating an electrical hazard.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural defect in a medical device that creates a potential electric hazard, which aligns with the rubric criteria for 'Severe' (structural vehicle defect or significant injury/property-damage reports) and the agency's Class II classification.

Plain-English summary

GE Healthcare, LLC is recalling four units of the Discovery NM/CT 670 DR, model 5376204-70-56. These medical imaging devices are intended for detecting, localizing, and diagnosing diseases and organ function, including cardiovascular disease, neurological disorders, and cancer.

The recall is due to a potential electrical hazard. When the system was installed, the Main disconnect switch, the EPO button on the A1 panel, and the Remote EPO button(s) may not have been wired correctly. This defect could result in these controls failing to shut off all power to the entire system as intended.

The affected units were distributed in California, the District of Columbia, Ohio, Utah, Wisconsin, and Canada. The specific serial numbers for the recalled units are DDRW34032, DDRX34038, DDRX34041, and DDRX34045. The GTIN for the product is 00840682124393.

The recalled product

Product
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 c
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Imaging Equipment
Hazard
Affected units
4

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • GTIN 00840682124393 Serial Numbers: DDRW34032
  • DDRX34038
  • DDRX34041
  • DDRX34045

Distribution

Distributed in 5 states:

Part of a larger recall action

This product is one of 3 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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