Class II U.S. Food and Drug Administration

GE Healthcare Centricity PACS Server V7, intended for managing digital medical images recall: Under certain conditions historical imaging data migrated from a legacy

Recall published last month

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.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-3169-2026
Published
September 23, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
GE Healthcare
Product type
Medical devices
Units affected
116 systems
Distribution
Nationwide
Made in
United States
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
UPC codes
00195278882585

Products covered by this recall

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

Check your product

The notice names 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00195278882585

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

GE Healthcare — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: GE Healthcare — 500 W Monroe St, Chicago, IL, 60661-3671

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was GE Healthcare medical devices 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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00195278882585. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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