GE Healthcare Recalls Centricity Universal Viewer Due to Patient Data Error
GE Healthcare is recalling Centricity Universal Viewer software because remote comparison studies may display incorrect patient data without a warning icon.
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 involves a risk-of-harm product (medical imaging software) where incorrect patient data association could lead to misdiagnosis or treatment errors, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
GE Healthcare, LLC is recalling the Centricity Universal Viewer with Cross Enterprise Display, specifically versions 6.0 SP1 and higher. The recall was initiated by the U.S. Food and Drug Administration under recall number Z-0195-2019.
The recall is due to a software defect where remote comparison studies may be associated with the wrong patient. Additionally, the system may fail to display a caution icon to alert users to this discrepancy. This issue could lead to healthcare providers reviewing medical images that do not belong to the patient currently being treated.
The affected product is identified by System ID 315470CPUWPV, UDI # 8406821038, and 00DE # 2090255-001. The distribution pattern is listed as NY. Healthcare facilities and users of this software should contact GE Healthcare for further instructions on how to resolve the issue.
The recalled product
- Product
- Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 1
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)
- SYSTEM ID: 315470CPUWPV UDI #: 8406821038 00DE #: 2090255-001
Distribution
Distributed in 1 state:
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