Ge Healthcare Recalls Imagecast PACS Software Due to Image Context Defect
Ge Healthcare is recalling Imagecast PACS software versions prior to 10.6 Update Package 18 because a defect causes images to be out of context with clinical information.
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 imaging software) where injury has not yet been reported, fitting the High severity criteria for theoretical hazards without confirmed harm.
Plain-English summary
Ge Healthcare is recalling specific versions of its Imagecast PACS with Centricity RIS-IC software. The affected units are versions prior to 10.6 Update Package 18, including Imagecast PACS versions 3.5.69, 3.5.86, 3.5.87, and 3.6. The recall covers 13 units distributed nationwide in the United States.
The recall was initiated because a software defect was discovered that causes images to be out of context with clinical information. This system is intended for use by trained medical professionals to acquire, transmit, process, and store images and data in a clinical environment.
Healthcare facilities using the affected software should contact Ge Healthcare for instructions on how to resolve the defect. The source text does not report any specific injuries or illnesses associated with this software defect.
The recalled product
- Product
- Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general pur
- Manufacturer
- Ge Healthcare It
- Category
- Medical Device — Software
- Affected units
- 13
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 (3)
- Imagecast PACS 3.5.69
- 3.5.86
- 3.5.87 and 3.6 with Centricity. RIS-IC 10.6 versions prior to update Package 18.
Distribution
Distributed nationwide across the United States.
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