Merge Healthcare Recalls PACS Workstations Due to Inaccurate Measurements
Merge Healthcare is recalling 20 Merge PACS and Merge OrthoPACS workstations because a software issue may cause measurements to be displayed inaccurately.
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 medical device where a software defect may lead to inaccurate diagnostic measurements. This poses a risk of harm through potential misdiagnosis, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Merge Healthcare, Inc. is recalling 20 units of Merge PACS and Merge OrthoPACS medical imaging diagnostic workstations. The recall is due to a software issue that may cause measurements to be displayed inaccurately.
The affected units are software version V9.5, identified by UDI (01)00842000101239(10)9.5.0(11)260409. These products were distributed nationwide in the United States, specifically in the states of California, Florida, Kentucky, Nebraska, and Washington.
Healthcare facilities should contact Merge Healthcare, Inc. for further instructions regarding the recall and potential remediation of the software issue.
The recalled product
- Product
- Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
- Manufacturer
- Merge Healthcare, Inc.
- Hazard
- Affected units
- 20
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 (1)
- Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409
Distribution
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