Class IIOngoingZ-1484-2025
GE Healthcare recalls GE Healthcare Centricity PACS-IW (PACS-IW)
GE HealthcareChicago, IL, United StatesReported Apr 9, 2025 · 1 year ago
Legal News Analyst ·
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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 information
- UDI
- t Required, System ID HCIT4250187IW; Model/Catalog/Code # 2042988-001, Installed Product ID 613493-Centricity PACS-IW-02292544
- UDI
- t Required, System ID HCIT4507688PACS; Model/Catalog/Code # 2049587-009, Installed Product ID 4276-1-Centricity PACS-IW-00558274
- UDI
- t Required, System ID PACS-IW-168; Model/Catalog/Code # 2049587-011, Installed Product ID 12830-1-Centricity PACS-IW-00558312
- UDI
- t Required, System ID PACS-IW-477; Model/Catalog/Code # 2049587-011, Installed Product ID 4352-1-Centricity PACS-IW-00558316
- UDI
- t Required, System ID PACS-IW-89; Model/Catalog/Code # 2049587-012, Installed Product ID 100858-1-Centricity PACS-IW-00558426
- UDI
- t Required, System ID PACS-IW-412; Model/Catalog/Code # 2049587-012, Installed Product ID 4294-1-Centricity PACS-IW-00558379
- UDI
- t Required, System ID PACS-IW-304; Model/Catalog/Code # 2049587-012, Installed Product ID 13039-1-Centricity PACS-IW-00558385
- UDI
- t Required, System ID PACS-IW-313; Model/Catalog/Code # 2049587-012, Installed Product ID 4744-1-Centricity PACS-IW-00558373
- UDI
- t Required, System ID PACS-IW-444; Model/Catalog/Code # 2049587-012, Installed Product ID 101216-1-Centricity PACS-IW-00558356
- UDI
- t Required, System ID PACS-IW-544; Model/Catalog/Code # 2049587-012, Installed Product ID 4361-1-Centricity PACS-IW-00558343
- UDI
- t Required, System ID PACS-IW-240; Model/Catalog/Code # 2049587-012, Installed Product ID 4393-1-Centricity PACS-IW-00558328
- UDI
- t Required, System ID PACS-IW-96; Model/Catalog/Code # 2049587-012, Installed Product ID 4573-1-Centricity PACS-IW-00558420
- UDI
- t Required, System ID PACS-IW-114; Model/Catalog/Code # 2049587-012, Installed Product ID 4506-1-Centricity PACS-IW-00558345
- UDI
- t Required, System ID PACS-IW-572; Model/Catalog/Code # 2049587-012, Installed Product ID AZ4030-Centricity PACS-IW-02336621
- UDI
- t Required, System ID AZ4030PC01; Model/Catalog/Code # 2049587-012, Installed Product ID 324462-Centricity PACS-IW-01431554
- UDI
- t Required, System ID HCIT4114037PIW; Model/Catalog/Code # 2049587-012, Installed Product ID 280801-Centricity PACS-IW-01431490
- UDI
- t Required, System ID HCIT4096486IW; Model/Catalog/Code # 2049587-012, Installed Product ID 307319-Centricity PACS-IW-01444609
- UDI
- t Required, System ID 2919183PACSIW; Model/Catalog/Code # 2049587-012, Installed Product ID KW1112-Centricity PACS-IW-00168151
- UDI
- t Required, System ID KW1112PC01; Model/Catalog/Code # 2049587-015, Installed Product ID X9003074 - RMUE01-Centricity PACS-IW-00001801
- UDI
- t Required, System ID RMUE01PC01; Model/Catalog/Code # 2049587-015, Installed Product ID KW1018-Centricity PACS-IW-01422962
- UDI
- t Required, System ID KW1018PC01; Model/Catalog/Code # 2049587-015, Installed Product ID KW1001-Centricity PACS-IW-00164288
- UDI
- t Required, System ID KW1001PC02; Model/Catalog/Code # 2049587-015, Installed Product ID KW1019-Centricity PACS-IW-00115173
- UDI
- t Required, System ID KW1019PC01; Model/Catalog/Code # 2049587-015, Installed Product ID PL2997-Centricity PACS-IW-00038793
- UDI
- t Required, System ID PL2997RW01; Model/Catalog/Code # 2049587-015, Installed Product ID PL1822-Centricity PACS-IW-00038825
- UDI
- t Required, System ID PL1822RW02; Model/Catalog/Code # 2049587-015, Installed Product ID TBD-Centricity PACS-IW-01273193
- UDI
- t Required, System ID RU1016ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU1241-Centricity PACS-IW-01273216
- UDI
- t Required, System ID RU1241RW01; Model/Catalog/Code # 2049587-015, Installed Product ID RU1493-Centricity PACS-IW-01273220
- UDI
- t Required, System ID RU1493ID01; Model/Catalog/Code # 2049587-015, Installed Product ID TBD-Centricity PACS-IW-01273244
- UDI
- t Required, System ID RU2967RW01; Model/Catalog/Code # 2049587-015, Installed Product ID RU2420-Centricity PACS-IW-01273234
- UDI
- t Required, System ID RU2420ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU3262-Centricity PACS-IW-01273245
- UDI
- t Required, System ID RU3262ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU8052-Centricity PACS-IW-02337508
- UDI
- t Required, System ID RU8052ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU6248-Centricity PACS-IW-01273279
- UDI
- t Required, System ID RU6248ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU8071-Centricity PACS-IW-01273295
- UDI
- t Required, System ID RU8071ID01; Model/Catalog/Code # 2049587-015, Installed Product ID -Centricity PACS-IW-01273233
- UDI
- t Required, System ID RU2371ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU3880-Centricity PACS-IW-01273266
- UDI
- t Required, System ID RU3880ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU7576-Centricity PACS-IW-01273287
- UDI
- t Required, System ID RU7576ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU2527-Centricity PACS-IW-01273235
- UDI
- t Required, System ID RU2527ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU2878-Centricity PACS-IW-01273243
- UDI
- t Required, System ID RU2878ID01; Model/Catalog/Code # 2049587-015, Installed Product ID TBD-Centricity PACS-IW-01273306
- UDI
- t Required, System ID RU8370ID01; Model/Catalog/Code # 2049587-015, Installed Product ID TBD-Centricity PACS-IW-01273258
- UDI
- t Required, System ID RU3625ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU1469-Centricity PACS-IW-01273219
- UDI
- t Required, System ID RU1469ID01; Model/Catalog/Code # 2049587-015, Installed Product ID 16757644-Centricity PACS-IW-01273200
- UDI
- t Required, System ID RU1095ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU1279-Centricity PACS-IW-02337628
- UDI
- t Required, System ID RU1279RW03; Model/Catalog/Code # 2049587-015, Installed Product ID RU8321-Centricity PACS-IW-01273303
- UDI
- t Required, System ID RU8321ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU1130-Centricity PACS-IW-01273210
- UDI
- t Required, System ID RU1130ID01; Model/Catalog/Code # 2049587-015, Installed Product ID TBD-Centricity PACS-IW-01273262
- UDI
- t Required, System ID RU3828ID01; Model/Catalog/Code # 2049587-015, Installed Product ID TBD-Centricity PACS-IW-01273224
- UDI
- t Required, System ID RU1669ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU8953-Centricity PACS-IW-01273311
- UDI
- t Required, System ID RU8953ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU2367-Centricity PACS-IW-01273232
- UDI
- t Required, System ID RU2367ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU1026-Centricity PACS-IW-01273195
- UDI
- t Required, System ID RU1026ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU8036-Centricity PACS-IW-01273293
- UDI
- t Required, System ID RU8036ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU7564-Centricity PACS-IW-01273286
- UDI
- t Required, System ID RU7564ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU3476-Centricity PACS-IW-01273251
- UDI
- t Required, System ID RU3476ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU3610-Centricity PACS-IW-01273257
- UDI
- t Required, System ID RU3610ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU1028-Centricity PACS-IW-01273197
- UDI
- t Required, System ID RU1028ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU1022-Centricity PACS-IW-01273194
- UDI
- t Required, System ID RU1022ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU5442-Centricity PACS-IW-01273277
- UDI
- t Required, System ID RU5442ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU3883-Centricity PACS-IW-01273267
- UDI
- t Required, System ID RU3883ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU3467-Centricity PACS-IW-01273250
- UDI
- t Required, System ID RU3467ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU3663-Centricity PACS-IW-01273259
- UDI
- t Required, System ID RU3663ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU7905-Centricity PACS-IW-01273291
- UDI
- t Required, System ID RU7905ID01; Model/Catalog/Code # 2049587-015, Installed Product ID TBD-Centricity PACS-IW-01273256
- UDI
- t Required, System ID RU3593ID01; Model/Catalog/Code # 2049587-015, Installed Product ID TBD-Centricity PACS-IW-01273218
- UDI
- t Required, System ID RU1298ID01; Model/Catalog/Code # 2049587-015, Installed Product ID TBD-Centricity PACS-IW-01273296
- UDI
- t Required, System ID RU8151ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU8607-Centricity PACS-IW-01273308
- UDI
- t Required, System ID RU8607ID01; Model/Catalog/Code # 2049588-012 , Installed Product ID 4345-1-Centricity PACS-IW-00558548
- UDI
- t Required, System ID PACS-IW-17; Model/Catalog/Code # 2049588-012 , Installed Product ID 101792-1-Centricity PACS-IW-00558370
- UDI
- t Required, System ID DRMC00558370; Model/Catalog/Code # 2049588-012 , Installed Product ID 4378-1-Centricity PACS-IW-00558498
- UDI
- t Required, System ID PACS-IW-445; Model/Catalog/Code # 2049588-012 , Installed Product ID 100663-1-Centricity PACS-IW-00558514
- UDI
- t Required, System ID 1-125580707; Model/Catalog/Code # 2049588-012 , Installed Product ID 100702-1-Centricity PACS-IW-00558539
- UDI
- t Required, System ID PACS-IW-152; Model/Catalog/Code # 2049588-012 , Installed Product ID 101625-1-Centricity PACS-IW-00558531
- UDI
- t Required, System ID 1-271709371; Model/Catalog/Code # 2049588-012 , Installed Product ID 4593-1-Centricity PACS-IW-00558488
- UDI
- t Required, System ID PACS-IW-147; Model/Catalog/Code # 2049588-012 , Installed Product ID 100009-1-Centricity PACS-IW-00558560
- UDI
- t Required, System ID PACS-IW-549; Model/Catalog/Code # 2049588-012 , Installed Product ID 100838-1-Centricity PACS-IW-00558532
- UDI
- t Required, System ID PACS-IW-153; Model/Catalog/Code # 2049588-012 , Installed Product ID 4694-1-Centricity PACS-IW-00558556
- UDI
- t Required, System ID PACS-IW-141; Model/Catalog/Code # 2049588-012 , Installed Product ID 4358-1-Centricity PACS-IW-00558564
- UDI
- t Required, System ID PACS-IW-418; Model/Catalog/Code # 2049588-012 , Installed Product ID 13095-1-Centricity PACS-IW-00558534
- UDI
- t Required, System ID PACS-IW-46; Model/Catalog/Code # 2049588-012 , Installed Product ID 4301-1-Centricity PACS-IW-00558525
- UDI
- t Required, System ID PACS-IW-355; Model/Catalog/Code # 2049588-012 , Installed Product ID 4383-1-Centricity PACS-IW-00558533
- UDI
- t Required, System ID PACS-IW-484; Model/Catalog/Code # 2049588-012 , Installed Product ID 319674-Centricity PACS-IW-01431535
- UDI
- t Required, System ID HCIT2882349PW03; Model/Catalog/Code # 2052829-001, Installed Product ID 4300-1-Centricity PACS-IW-00558207
- UDI
- t Required, System ID PACS-IW-340
Show 72 more code fieldsShow fewer
What the firm is doing
GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 02/19/2025 by letter delivered using traceable means. The notice explained the issue, safety issue, and requested the following actions be taken: "You can continue to use your device. Please ensure all potential users in your facility are made aware of this safety notification. Please ensure you have implemented the actions below: 1: Ensure your hospital network is secure and 2: Outside of the hospital network implement additional safeguards such as a VPN. Please retain this document for your records. Please complete and return the attached acknowledgement form to recall.85480@gehealthcare.com." "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." Per status report 05/23/2025, the firm send a follow-up notice dated 05/13/2025 providing an installation manual addendum that provides instructions for changing passwords.
DistributionShow detailsHide
Worldwide distribution.
Class IIWhat this means
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1484-2025
- FDA 510(k) clearance · K123174The device's official FDA premarket clearance record
- FDA device classification · LLZOfficial FDA classification for this device type
- CFR regulation · 21 CFR 892.2050The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find GE HealthcareSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus
Legal News Analyst
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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