| | Class 2 Device Recall GE Healthcare |  |
| Date Initiated by Firm | February 19, 2025 |
|---|
| Date Posted | March 28, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1484-2025 |
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| Recall Event ID |
96375 |
| 510(K)Number | K123174 |
|---|
| Product Classification |
System, image processing, radiological - Product Code LLZ
|
| Product | 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. |
|---|
| Code Information |
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. |
Recalling Firm/
Manufacturer |
GE Healthcare
500 W Monroe St
Chicago IL 60661-3671
|
| For Additional Information Contact | GE Healthcare
800-437-1171 |
|---|
Manufacturer 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. |
|---|
FDA Determined
Cause 2 | Software design |
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| Action | 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. |
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| Quantity in Commerce | 82 units |
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| Distribution | Worldwide distribution. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = LLZ
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