GE radiology viewer may show patient information not matching displayed images
GE Healthcare is recalling Centricity Universal Viewer Zero Footprint Client because under certain workflows the patient information shown may not match the images displayed.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: images may be displayed against the wrong patient's information, and no injuries are stated in the source.
Plain-English summary
GE Healthcare is recalling the Centricity Universal Viewer Zero Footprint Client, model numbers 2110344-039, 2110344-046 and 2110344-047, a radiological image processing system. About 250 units were distributed worldwide, covering the United States nationwide and more than thirty other countries. The FDA has classified this recall as Class II.
Under certain workflows, patient information shown in the viewer may not match the images displayed. The issue affects Zero Footprint Client versions ZFP v6.0 SP11.6, SP11.6.0.1 and SP11.6.1 on systems with Patient Timeline installed.
Affected systems carry UDI/DI 00840682102988 for model 2110344-039, with individual system ID numbers listed in the FDA enforcement record.
Facilities can identify affected systems by the model and software version above, and may contact GE Healthcare for further information.
The recalled product
- Product
- GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological
- Manufacturer
- GE Healthcare
- Affected units
- 250
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)
- 1) 2110344-039
- UDI/DI 00840682102988
- 4491-1-Centricity Universal Viewer Zero Footprint / ZFP-22180897
- 10908-1-Centricity Universal Viewer Zero Footprint / ZFP-25199248
- 10908-7-Centricity Universal Viewer Zero Footprint / ZFP-22203146
- 10908-7-Centricity Universal Viewer Zero Footprint / ZFP-25188736
- 4263-3-Centricity Universal Viewer Zero Footprint / ZFP-00106869
- 4263-3-Centricity Universal Viewer Zero Footprint / ZFP-00106870
- 4263-5-Centricity Universal Viewer Zero Footprint / ZFP-01300798
- 3064-15-Centricity Universal Viewer Zero Footprint / ZFP-25222931
- 3064-15-Centricity Universal Viewer Zero Footprint / ZFP-25248683
- 3064-15-Centricity Universal Viewer Zero Footprint / ZFP-25248688
- 3064-15-Centricity Universal Viewer Zero Footprint / ZFP-25248690
- 3064-15-Centricity Universal Viewer Zero Footprint / ZFP-25248695
- 3064-15-Centricity Universal Viewer Zero Footprint / ZFP-25248713
- 3064-15-Centricity Universal Viewer Zero Footprint / ZFP-25248716
- 3064-15-Centricity Universal Viewer Zero Footprint / ZFP-26608643
- 10458-9-Centricity Universal Viewer Zero Footprint / ZFP-26580437
- 10458-9-Centricity Universal Viewer Zero Footprint / ZFP-26694204
- 10458-9-Centricity Universal Viewer Zero Footprint / ZFP-26694229
Distribution
Distributed nationwide across the United States.
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