The Recall Desk
HighFDA (Devices)·Z-0121-2013·Announced 2012-10-31

GE Healthcare Recalls Discovery NM/CT 670 and NM 630 Systems

GE Healthcare is recalling 210 Discovery NM/CT 670 and NM 630 systems due to a potential safety issue where the table pallet may contact the detector during operation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

GE Healthcare, LLC is recalling 210 units of the GE Discovery NM/CT 670 and GE Discovery NM 630 systems. These are medical imaging tools used by healthcare professionals to detect and diagnose diseases, including cardiovascular disease, neurological disorders, and cancer.

The recall is due to a potential safety issue with the table pallet. During the scan setup, as the gantry rotates toward the scanning position, the edge of the table pallet may come into contact with the detector. This occurrence may damage the front edge of the pallet and impact operation safety.

The affected units were distributed worldwide, including in the United States and various international markets. Healthcare facilities should contact GE Healthcare for further instructions on how to address this issue.

The recalled product

Product
GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and
Manufacturer
GE Healthcare, LLC
Affected units
210

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 (20)

  • Mfg Lot or Serial # 21058
  • 21002
  • 21013
  • 21017
  • 21020
  • 21029
  • 21039
  • 21041
  • 21049
  • 21066
  • 21075
  • 21079
  • 21080
  • 21081
  • 21082
  • 21119
  • 21140
  • 21144
  • 21145
  • 21147

Distribution

Distributed nationwide across the United States.

The notice also names 25 states specifically: