Senographe Pristina
GE Medical Systems, LLC · GE HealthCare has become aware of a nonconformance to certain Senographe Pristina VIA systems. Specifically, in cases of 3D+2D manual mode where the acquisitio…
Open FDA's page for this record- Cfres ID
- 223533
- Product res number
- Z-0327-2027
- Event date initiated
- 2026-08-28
- Event date posted
- 2026-11-04
- Recall status
- Open, Classified
- Res event number
- 100070
- Product code
- MUE
- Product description
- Senographe Pristina
- Firm FEI number
- 2126677
- Recalling firm
- GE Medical Systems, LLC
- Address 1
- 3000 N Grandview Blvd
- City
- Waukesha
- State
- WI
- Postal code
- 53188-1615
- Additional info contact
- 262-544-3011
- Root cause description
- Radiation Control for Health and Safety Act
- Distribution pattern
- USA and OUS.
- Code info
GTIN(s): 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026, 00198953109281, 10198953054311, 10195278901764.
- 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).
- Action
GE 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.
- K numbers
- K162268
- Harmonized identifiers (openFDA)
- Device name
- Full Field Digital, System, X-Ray, Mammographic
- Medical specialty description
- Radiology
- Regulation number
- 892.1715
- Device class
- 2
- K number
- K110025, K200424, K243849, K211215, K211725, K151645, K111434, K111324, K202902, K254090, K123873, K163328, K253678, K162268, K163302, K170930, K241113, K122510, K220073, K192317, K123520, K103485, K123995, K120255, K212873, K193334, K130704, K173132, K121674, K133972, K193166, K110729, K162670, K122286, K182951, K254092, K172404, K211720, K111646, K110798 +16 more
- PMA number
- P990066, P050014, P030010, P010025, P080018, P010017
- Registration number
- 3021059265, 3005810333, 9611343, 3008833258, 3003775006, 3004485675, 3023003446, 3005406110, 3017375271, 3010398867, 9680027, 3001556265, 3031503890, 3035950510, 3009196578, 3012127758, 3003769120, 1423253, 3017585294, 3005877899, 3009963139, 8043728, 3008496839, 3006013411, 3004977335, 3005843418, 3001722928, 3015276088, 3003768251, 3005496266, 3010703925, 3005172103, 3009048384, 3008787461, 2433615, 3000126629, 3008355361, 3025442726, 1317307, 3009717300 +3 more
- FEI number
- 3021059265, 3002807317, 3005810333, 3008833258, 3003775006, 3004485675, 3002807903, 3023003446, 1000514697, 3005406110, 3017375271, 3010398867, 3001556265, 3031503890, 3035950510, 3009196578, 1000284313, 3012127758, 3003769120, 3017585294, 3005877899, 3009963139, 3008496839, 3006013411, 3004977335, 3005843418, 3001722928, 3015276088, 3003768251, 3005496266, 3003772616, 3010703925, 3005172103, 3009048384, 3008787461, 2433615, 3000126629, 3008355361, 3025442726, 1317307 +3 more