Class II Recall

GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2

Summary

The FDA issued a Class II for GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; by GE Healthcare. Reason: There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & C.

Details

Source

Device Recall

External ID

Z-1484-2025

Action Date

2025-04-09

Status

Ongoing

Product Description

GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2049587-012; 5) 2049587-015; 6) 2049588-012 ; 7) 2052829-001.

Lot/Code Info: Model/Catalog/Code # 2042988-001, Installed Product ID 707509-Centricity PACS-IW-01452391, UDI UDI Not Required, System ID HCIT4250187IW; Model/Catalog/Code # 2042988-001, Installed Product ID 613493-Centricity PACS-IW-02292544, UDI UDI Not Required, System ID HCIT4507688PACS; Model/Catalog/Code # 2049587-009, Installed Product ID 4276-1-Centricity PACS-IW-00558274, UDI UDI Not Required, System ID PACS-IW-168; Model/Catalog/Code # 2049587-011, Installed Product ID 12830-1-Centricity PACS-IW-00558312, UDI UDI Not Required, System ID PACS-IW-477; Model/Catalog/Code # 2049587-011, Installed Product ID 4352-1-Centricity PACS-IW-00558316, UDI UDI Not Required, System ID PACS-IW-89; Model/Catalog/Code # 2049587-012, Installed Product ID 100858-1-Centricity PACS-IW-00558426, UDI UDI Not Required, System ID PACS-IW-412; Model/Catalog/Code # 2049587-012, Installed Product ID 4294-1-Centricity PACS-IW-00558379, UDI UDI Not Required, System ID PACS-IW-304; Model/Catalog/Code # 2049587-012, Installed Product ID 13039-1-Centricity PACS-IW-00558385, UDI UDI Not Required, System ID PACS-IW-313; Model/Catalog/Code # 2049587-012, Installed Product ID 4744-1-Centricity PACS-IW-00558373, UDI UDI Not Required, System ID PACS-IW-444; Model/Catalog/Code # 2049587-012, Installed Product ID 101216-1-Centricity PACS-IW-00558356, UDI UDI Not Required, System ID PACS-IW-544; Model/Catalog/Code # 2049587-012, Installed Product ID 4361-1-Centricity PACS-IW-00558343, UDI UDI Not Required, System ID PACS-IW-240; Model/Catalog/Code # 2049587-012, Installed Product ID 4393-1-Centricity PACS-IW-00558328, UDI UDI Not Required, System ID PACS-IW-96; Model/Catalog/Code # 2049587-012, Installed Product ID 4573-1-Centricity PACS-IW-00558420, UDI UDI Not Required, System ID PACS-IW-114; Model/Catalog/Code # 2049587-012, Installed Product ID 4506-1-Centricity PACS-IW-00558345, UDI UDI Not Required, System ID PACS-IW-572; Model/Catalog/Code # 2049587-012, Installed Product ID AZ4030-Centricity PACS-IW-02336621, UDI UDI Not Required, System ID AZ4030PC01; Model/Catalog/Code # 2049587-012, Installed Product ID 324462-Centricity PACS-IW-01431554, UDI UDI Not Required, System ID HCIT4114037PIW; Model/Catalog/Code # 2049587-012, Installed Product ID 280801-Centricity PACS-IW-01431490, UDI UDI Not Required, System ID HCIT4096486IW; Model/Catalog/Code # 2049587-012, Installed Product ID 307319-Centricity PACS-IW-01444609, UDI UDI Not Required, System ID 2919183PACSIW; Model/Catalog/Code # 2049587-012, Installed Product ID KW1112-Centricity PACS-IW-00168151, UDI UDI Not Required, System ID KW1112PC01; Model/Catalog/Code # 2049587-015, Installed Product ID X9003074 - RMUE01-Centricity PACS-IW-00001801, UDI UDI Not Required, System ID RMUE01PC01; Model/Catalog/Code # 2049587-015, Installed Product ID KW1018-Centricity PACS-IW-01422962, UDI UDI Not Required, System ID KW1018PC01; Model/Catalog/Code # 2049587-015, Installed Product ID KW1001-Centricity PACS-IW-00164288, UDI UDI Not Required, System ID KW1001PC02; Model/Catalog/Code # 2049587-015, Installed Product ID KW1019-Centricity PACS-IW-00115173, UDI UDI Not Required, System ID KW1019PC01; Model/Catalog/Code # 2049587-015, Installed Product ID PL2997-Centricity PACS-IW-00038793, UDI UDI Not Required, System ID PL2997RW01; Model/Catalog/Code # 2049587-015, Installed Product ID PL1822-Centricity PACS-IW-00038825, UDI UDI Not Required, System ID PL1822RW02; Model/Catalog/Code # 2049587-015, Installed Product ID TBD-Centricity PACS-IW-01273193, UDI UDI Not Required, System ID RU1016ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU1241-Centricity PACS-IW-01273216, UDI UDI Not Required, System ID RU1241RW01; Model/Catalog/Code # 2049587-015, Installed Product ID RU1493-Centricity PACS-IW-01273220, UDI UDI Not Required, System ID RU1493ID01; Model/Catalog/Code # 2049587-015, Installed Product ID TBD-Centricity PACS-IW-01273244, UDI UDI Not Required, System ID RU2967RW01; Model/Catalog/Code # 2049587-015, Installed Product ID RU2420-Centricity PACS-IW-01273234, UDI UDI Not Required, System ID RU2420ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU3262-Centricity PACS-IW-01273245, UDI UDI Not Required, System ID RU3262ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU8052-Centricity PACS-IW-02337508, UDI UDI Not Required, System ID RU8052ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU6248-Centricity PACS-IW-01273279, UDI UDI Not Required, System ID RU6248ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU8071-Centricity PACS-IW-01273295, UDI UDI Not Required, System ID RU8071ID01; Model/Catalog/Code # 2049587-015, Installed Product ID -Centricity PACS-IW-01273233, UDI UDI Not Required, System ID RU2371ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU3880-Centricity PACS-IW-01273266, UDI UDI Not Required, System ID RU3880ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU7576-Centricity PACS-IW-01273287, UDI UDI Not Required, System ID RU7576ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU2527-Centricity PACS-IW-01273235, UDI UDI Not Required, System ID RU2527ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU2878-Centricity PACS-IW-01273243, UDI UDI Not Required, System ID RU2878ID01; Model/Catalog/Code # 2049587-015, Installed Product ID TBD-Centricity PACS-IW-01273306, UDI UDI Not Required, System ID RU8370ID01; Model/Catalog/Code # 2049587-015, Installed Product ID TBD-Centricity PACS-IW-01273258, UDI UDI Not Required, System ID RU3625ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU1469-Centricity PACS-IW-01273219, UDI UDI Not Required, System ID RU1469ID01; Model/Catalog/Code # 2049587-015, Installed Product ID 16757644-Centricity PACS-IW-01273200, UDI UDI Not Required, System ID RU1095ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU1279-Centricity PACS-IW-02337628, UDI UDI Not Required, System ID RU1279RW03; Model/Catalog/Code # 2049587-015, Installed Product ID RU8321-Centricity PACS-IW-01273303, UDI UDI Not Required, System ID RU8321ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU1130-Centricity PACS-IW-01273210, UDI UDI Not Required, System ID RU1130ID01; Model/Catalog/Code # 2049587-015, Installed Product ID TBD-Centricity PACS-IW-01273262, UDI UDI Not Required, System ID RU3828ID01; Model/Catalog/Code # 2049587-015, Installed Product ID TBD-Centricity PACS-IW-01273224, UDI UDI Not Required, System ID RU1669ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU8953-Centricity PACS-IW-01273311, UDI UDI Not Required, System ID RU8953ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU2367-Centricity PACS-IW-01273232, UDI UDI Not Required, System ID RU2367ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU1026-Centricity PACS-IW-01273195, UDI UDI Not Required, System ID RU1026ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU8036-Centricity PACS-IW-01273293, UDI UDI Not Required, System ID RU8036ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU7564-Centricity PACS-IW-01273286, UDI UDI Not Required, System ID RU7564ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU3476-Centricity PACS-IW-01273251, UDI UDI Not Required, System ID RU3476ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU3610-Centricity PACS-IW-01273257, UDI UDI Not Required, System ID RU3610ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU1028-Centricity PACS-IW-01273197, UDI UDI Not Required, System ID RU1028ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU1022-Centricity PACS-IW-01273194, UDI UDI Not Required, System ID RU1022ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU5442-Centricity PACS-IW-01273277, UDI UDI Not Required, System ID RU5442ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU3883-Centricity PACS-IW-01273267, UDI UDI Not Required, System ID RU3883ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU3467-Centricity PACS-IW-01273250, UDI UDI Not Required, System ID RU3467ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU3663-Centricity PACS-IW-01273259, UDI UDI Not Required, System ID RU3663ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU7905-Centricity PACS-IW-01273291, UDI UDI Not Required, System ID RU7905ID01; Model/Catalog/Code # 2049587-015, Installed Product ID TBD-Centricity PACS-IW-01273256, UDI UDI Not Required, System ID RU3593ID01; Model/Catalog/Code # 2049587-015, Installed Product ID TBD-Centricity PACS-IW-01273218, UDI UDI Not Required, System ID RU1298ID01; Model/Catalog/Code # 2049587-015, Installed Product ID TBD-Centricity PACS-IW-01273296, UDI UDI Not Required, System ID RU8151ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU8607-Centricity PACS-IW-01273308, UDI UDI Not Required, System ID RU8607ID01; Model/Catalog/Code # 2049588-012 , Installed Product ID 4345-1-Centricity PACS-IW-00558548, UDI UDI Not Required, System ID PACS-IW-17; Model/Catalog/Code # 2049588-012 , Installed Product ID 101792-1-Centricity PACS-IW-00558370, UDI UDI Not Required, System ID DRMC00558370; Model/Catalog/Code # 2049588-012 , Installed Product ID 4378-1-Centricity PACS-IW-00558498, UDI UDI Not Required, System ID PACS-IW-445; Model/Catalog/Code # 2049588-012 , Installed Product ID 100663-1-Centricity PACS-IW-00558514, UDI UDI Not Required, System ID 1-125580707; Model/Catalog/Code # 2049588-012 , Installed Product ID 100702-1-Centricity PACS-IW-00558539, UDI UDI Not Required, System ID PACS-IW-152; Model/Catalog/Code # 2049588-012 , Installed Product ID 101625-1-Centricity PACS-IW-00558531, UDI UDI Not Required, System ID 1-271709371; Model/Catalog/Code # 2049588-012 , Installed Product ID 4593-1-Centricity PACS-IW-00558488, UDI UDI Not Required, System ID PACS-IW-147; Model/Catalog/Code # 2049588-012 , Installed Product ID 100009-1-Centricity PACS-IW-00558560, UDI UDI Not Required, System ID PACS-IW-549; Model/Catalog/Code # 2049588-012 , Installed Product ID 100838-1-Centricity PACS-IW-00558532, UDI UDI Not Required, System ID PACS-IW-153; Model/Catalog/Code # 2049588-012 , Installed Product ID 4694-1-Centricity PACS-IW-00558556, UDI UDI Not Required, System ID PACS-IW-141; Model/Catalog/Code # 2049588-012 , Installed Product ID 4358-1-Centricity PACS-IW-00558564, UDI UDI Not Required, System ID PACS-IW-418; Model/Catalog/Code # 2049588-012 , Installed Product ID 13095-1-Centricity PACS-IW-00558534, UDI UDI Not Required, System ID PACS-IW-46; Model/Catalog/Code # 2049588-012 , Installed Product ID 4301-1-Centricity PACS-IW-00558525, UDI UDI Not Required, System ID PACS-IW-355; Model/Catalog/Code # 2049588-012 , Installed Product ID 4383-1-Centricity PACS-IW-00558533, UDI UDI Not Required, System ID PACS-IW-484; Model/Catalog/Code # 2049588-012 , Installed Product ID 319674-Centricity PACS-IW-01431535, UDI UDI Not Required, System ID HCIT2882349PW03; Model/Catalog/Code # 2052829-001, Installed Product ID 4300-1-Centricity PACS-IW-00558207, UDI UDI Not Required, System ID PACS-IW-340.

Quantity Affected: 82 units

Reason for Recall

There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

Distribution

Worldwide distribution.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-02-19

Company

GE Healthcare

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 182 device recalls issued in the same week, part of 403 device-related FDA actions this month.

GE Healthcare has 32 FDA actions in our database, including 18 recalls and 9 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 18 recalls and 9 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1484-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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