The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2715-2016·Announced 2016-09-14

Merge RadSuite software recalled due to patient demographic misapplication risk

Merge Healthcare is recalling RadSuite software at 10 sites because patient demographics may be incorrectly applied to other patients' studies.

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 3/5 (High).

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 is classified as FDA Class II. The hazard involves the misapplication of patient demographics to other patients' studies, which is a risk-of-harm product issue where injury has not yet been reported in the source text.

Plain-English summary

Merge Healthcare, Inc. is recalling RadSuite software, a radiological image processing system, at 10 medical facilities. The recall affects specific versions of the software (5.30.8, 5.35.3, 5.35.4, 5.35.5, 8.30.7.3, 8.30.7.4, 8.30.7.5, and 8.30.7.7) only when configured with specific conditions involving the IPID (Issuer of Patient ID) morpher and aggregating morpher settings.

The hazard exists because, when RadSuite is used with IPID as part of the "Patient Identifier," it is possible in some circumstances that the demographics of one patient will be applied to a study or studies for another patient. This misapplication of patient data could lead to incorrect medical records or diagnostic errors.

The affected software was distributed to medical facilities in Alabama, Michigan, Missouri, Pennsylvania, Tennessee, and Texas. The source text does not specify instructions for consumers or patients, as the product is a professional medical device used by healthcare facilities.

The recalled product

Product
Merge RadSuite software. Radiological image processing system.
Manufacturer
Merge Healthcare, Inc.
Category
Medical Device — Software
Hazard
Affected units
10

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 (12)

  • RadSuite Versions: 5.30.8
  • 5.35.3
  • 5.35.4
  • 5.35.5
  • 8.30.7.3
  • 8.30.7.4
  • 8.30.7.5
  • 8.30.7.7 are affected
  • (2) Must use IPID morphers (3) Must Define a Defaultvalue in the IPID Morpher
  • (4) Must use the Aggregating Morpher
  • (5) Must not set OverwritelfPresent=false
  • this excludes direct DICOM stores to the EA).

Distribution

Distributed in 6 states:

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