Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions
Summary
The FDA issued a Class II for Centricity PACS Server V7, intended for managing digital medical images and asso by GE Healthcare. Reason: Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occ.
Details
Source
Device Recall
External ID
Z-3169-2026
Action Date
2026-09-23
Status
Ongoing
Category
device
Product Description
Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions
Lot/Code Info: 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
Quantity Affected: 116 systems
Reason for Recall
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.
Distribution
Worldwide - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-31
Company
Chicago, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 203 device recalls issued in the same week, part of 445 device-related FDA actions this month.
GE Healthcare has 32 FDA actions in our database, including 24 recalls and 8 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE Healthcare) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE Healthcare have FDA actions?
GE Healthcare has 32 FDA actions in our database, including 24 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3169-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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