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U.S. Department of Health and Human Services

Class 2 Device Recall Senographe Pristina 3D

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 Class 2 Device Recall Senographe Pristina 3Dsee related information
Date Initiated by FirmAugust 28, 2026
Date PostedNovember 04, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0328-2027
Recall Event ID 100070
PMA NumberP130020 
Product Classification Digital breast tomosynthesis - Product Code OTE
ProductSenographe Pristina 3D
Code Information N/A
FEI Number 2126677
Recalling Firm/
Manufacturer		 GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-544-3011
Manufacturer Reason
for Recall		GE HealthCare has become aware of a nonconformance to certain Senographe Pristina VIA systems. Specifically, in cases of 3D+2D manual mode where the acquisition configuration of the anode track/filter combination is different, it can result in the following: the collimator blades might be visible in the image, or the collimator might be open more than expected, and an incorrect collimator filter might be used with respect to the anode track selected This issue could result in a minor additional X-ray dose being delivered to the patient and obvious artifacts in the image (collimator blades).
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionGE HealthCare will send a customer letter dated August 28, 2026, that provides safety instructions for immediate mitigation of the incorrect configuration of the collimator anode track / filter in manual mode during 3D+2D acquisitions. GE HealthCare will correct all affected Senographe Pristina VIA systems by upgrading the software at no cost to the customer. 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.
DistributionUSA and OUS.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = OTE
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