CLASS II ONGOING Device recall · Reported 23 Sep 2026 · FDA Enforcement Report

Centricity PACS Server V7, intended recalled by GE Healthcare

GE Healthcare is recalling Centricity PACS Server V7, intended for managing digital medical images and associated, distributed nationwide in the US. The recall was initiated on 31 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-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 recalled116 systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3169-2026
FDA event ID: 99661
Recalling firm: GE Healthcare, Chicago, IL
Classification: Class II
Status: Ongoing
Recall initiated: 31 Jul 2026
FDA classified: 15 Sep 2026
Reported: 23 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

31 Jul 2026	Recall initiated by company
15 Sep 2026	Classified by FDA	+46 days
23 Sep 2026	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Worldwide - US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Worldwide - US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 29 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 99661

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026	CLASS II	Centricity PACS V2, V3, V4, V6, V7 recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
23 Sep 2026	CLASS II	Centricity Enterprise Archive V2, V3, and V4 recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
23 Sep 2026	CLASS II	Core Services Hub V8, a set of backend services including recalled	GE Healthcare	Other	Nationwide
23 Sep 2026	CLASS II	Workflow Core Services V8, intended to provide set recalled	GE Healthcare	Other	Nationwide
23 Sep 2026	CLASS II	Enterprise Archive V8 recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide

More recalls from GE Healthcare

All 518

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	Enterprise Archive V8 recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Workflow Core Services V8, intended to provide set recalled	GE Healthcare	Other	Nationwide
23 Sep 2026Device	CLASS II	Core Services Hub V8, a set of backend services including recalled	GE Healthcare	Other	Nationwide
23 Sep 2026Device	CLASS II	Centricity Enterprise Archive V2, V3, and V4 recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Centricity PACS V2, V3, V4, V6, V7 recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide

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