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Centricity PACS Server V7, intended for managing digital… recallZ-3169-2026 · GE Healthcare · initiated Jul 31, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Healthcare or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.

FDA root cause category: Under Investigation by firm

What the company is doing

An URGENT MEDICAL DEVICE CORRECTION notification letter dated 7/31/26 was sent to customers. Actions to be taken by Customer/User Pending corrections from GE HealthCare, you can continue to use your systems by following the instructions below. 1. Do not perform any new inbound data (DICOM) migration projects. Please contact GE HealthCare before starting any new migration projects. 2. If using Enterprise Archive with Core Services Hub/Workflow Core Services, when reviewing or exporting prior imaging studies after migration to Enterprise Archive, verify that the study and images within the study are associated with the correct patient as follows: At the Study level: " Compare name, date of birth, and patient identifiers only if burned-in or embedded in the image. Do not rely on patient information in the image overlays that can be toggled on and off. " If burned-in or embedded patient identifiers are not available, compare with prior studies based on patient anatomy, implants, or unique anatomical features. At the Image level: " Confirm that the images within the study do not belong to different patients based on acquisition date and time or other patient identifiers. Please maintain any previous source systems or migration servers pending correction of this issue by GE HealthCare. Please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions above. Please retain this document for your records. Please complete and return the attached acknowledgement form electronically via FMI 85492 Digital Response Form or print, fill out manually, scan, and email to [email protected]. 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.

Recall details

Recall number
Z-3169-2026
Status
Open, Classified
Initiated by the company
Jul 31, 2026
Posted by the FDA
Sep 15, 2026
Recalling firm
GE Healthcare
Quantity
116 systems
Product code
LLZ
FDA submissions
K043415, K110875
Distribution
Worldwide - US Nationwide distribution.

Product description

Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

UDI-DI: 00195278882585; System IDs: 847NWCPVSW 847NWCPVSW2 NORTHWEST25206018 207795PVSWC3 207795PVSWC1 207795PVSWC2 604520GEPACS 613548IMSA 613548IMSB 613548TESTIMS 613548GEPACS EG1055PC01 B4191728 C4191734 D4191718 E4191720 tobecreated HHEI02CS01 UC1989CS01 CPACS Testsystem Not Available HCIT5592143PACS JL1758 JD1266 JL1760 JAS004 JL1762 JAS042 JL1757 JL1761 JL1759 KW1018PP01 ALRAZIIMS LB1279PC02 BMALTA25 PIV-PIMS1 SA2591PP01 SA2039PP01 SA2315PP12 KAMCJIMS2 SA1208PP01 SA2000PP01 SA1006PP07 KFHIMS2 KAHIMS2 MKNSHIMS2 ZA2895PACS02 FEG85600 FEG85608 FEG34405 FEG34406 FEB92518 FEB92519 FEE07A22 FEE07A23 FEG85700 FEG85704 FE410911 FE410912 IMSTEST TBC DE619840 DE619846 DEM88511 DEM88512 DEM87116 DEM87121 DEI12311 DEI12312 DEP00203 20034126 NE465120 NE670325 NE673137 NE300609 NE219643 FE816139 FE816140 FE8161102 DPP03300 DPP03301 DPP03302 DPP03303 DPP03305 FEG51800 FEF70522 FEF70523 MEX61704 MEX67314 GPX24300 NPV73804 25277590 NE203141 NE740521 NE216225 NE487826 MEX67605 NE723605 NEV07027 NE748614 NEV13618 NEV06838 NE304907 NE223245 NE419140 NEV44001 NPV84521 NEV44017 NEV44018 NEV44034 NE741437 NEV35826 NE688826 GEE34022 06002PAC37 06051PAC01

Other devices under the same FDA submission

6 devices cleared under K043415, K110875 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 99661).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page