Merge Healthcare Recalls RadSuite Software Due to Missing Studies
Merge Healthcare is recalling RadSuite software versions where studies may be missing from archives before watermarking.
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 is classified as FDA Class II and involves a risk-of-harm product (medical software) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Merge Healthcare, Inc. is recalling specific versions of RadSuite software. The recall is due to a potential patient safety issue where multiple studies were missing at a customer location and did not make it to the archive before watermarking.
The issue is present only in specific software versions when a reverse workflow is used. The standard workflow is not impacted. The affected versions include 2004-R6.x, 5.10.x, 5.20, 5.25, and various 5.30.x and 5.35.x series versions, as well as 8.30.0.
Distribution was nationwide to medical facilities, with government distribution made to Louisiana and Oklahoma. Approximately 45 sites potentially have the affected versions. The FDA has classified this as a Class II recall.
The recalled product
- Product
- RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 45
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)
- 5.10.x
- 5.20
- 5.25
- 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
Distribution
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