The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0794-2016·Announced 2016-02-17

Merge Healthcare Recalls RadSuite Picture Archive System for Measurement Errors

Merge Healthcare is recalling RadSuite picture archive systems because they may display incorrect Standardized Uptake Values (SUV). The recall covers 164 units distributed nationwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential measurement errors in a diagnostic support system, which is a significant quality issue but does not involve direct physical injury or high-risk pathogens, fitting the Moderate category for non-physical defects without reported harm.

Plain-English summary

Merge Healthcare, Inc. is recalling RadSuite, a picture archive and communications system, due to a potential for incorrect Standardized Uptake Values (SUV) measurements. The recall affects 164 units across various versions, including 5.30.x, 5.35.x, and 8.30.x series.

The affected units were distributed nationwide to facilities in states including Minnesota, Wisconsin, Illinois, Pennsylvania, Alabama, Missouri, Montana, Arizona, California, Ohio, Florida, South Carolina, Michigan, Tennessee, Colorado, Nevada, Indiana, New York, Maryland, Arkansas, Kansas, Iowa, Texas, Oklahoma, North Carolina, Washington, and the District of Columbia.

Healthcare facilities using these systems should contact Merge Healthcare for instructions on how to resolve the measurement issue. The source text does not report any specific illnesses or injuries associated with this defect.

The recalled product

Product
RadSuite, a picture archive and communications system. Model Numbers Versions 5.30.0, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7…
Manufacturer
Merge Healthcare, Inc.
Category
Medical Device — Imaging Software
Hazard
Affected units
164

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)

  • Versions 5.30.0
  • 5.30.1
  • 5.30.2
  • 5.30.2 SB0344
  • 5.30.3
  • 5.30.4
  • 5.30.4 HF0418E
  • 5.30.5
  • 5.30.5 HF0404E
  • 5.30.5 HF0413E
  • 5.30.5 HF390E
  • 5.30.5 SB0368
  • 5.30.6
  • 5.30.6 HF0405E
  • 5.30.6 HF0406E
  • 5.30.7
  • 5.30.7 HF0429E
  • 5.30.7 HF0441E
  • 5.30.7 HF0446E
  • 5.30.7 HF0470E

Distribution

Distributed nationwide across the United States.

The notice also names 27 states specifically:

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