Recalls / —

—#168145

Product

Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.

FDA product code

LLZ — System, Image Processing, Radiological

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K150420

Affected lot / code info

SYSTEM ID: 315470CPUWPV  UDI #: 8406821038 00DE #: 2090255-001

Why it was recalled

Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present.

Root cause (FDA determination)

Component design/selection

Action the firm took

On August 30, 2018, GE Healthcare sent Urgent Medical Device Correction letters to customers with affected units. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Recalling firm

Firm

GE Healthcare, LLC

Address

3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern

NY

Timeline

Recall initiated

2018-08-30

Terminated

2022-08-31

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #168145. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.