The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1484-2025·Announced 2025-04-09

GE Healthcare PACS-IW Software Security Vulnerability Affects Patient Data Access

GE Healthcare recalled Centricity PACS-IW and related medical imaging software due to a security vulnerability allowing service credentials to be identified, potentially enabling unauthorized system access and patient data manipulation.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm medical device with a security vulnerability that could allow unauthorized access and patient data manipulation. No actual unauthorized access or patient harm has been reported, making this a theoretical hazard that meets the Score 3 criterion per the rubric.

Plain-English summary

GE Healthcare has issued a recall for Centricity PACS-IW, Centricity Universal Viewer (UV), Centricity Radiology RA600, and Centricity Cardiology CA1000 medical imaging software systems. These systems contain a security vulnerability where service login credentials can be identified by unauthorized users.

A malicious actor with access to these credentials could gain access to the system and potentially manipulate patient data. Approximately 82 units of the affected systems are distributed worldwide.

No unauthorized access or patient data manipulation incidents have been reported related to this vulnerability.

The recalled product

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.
Manufacturer
GE Healthcare
Category
Medical Device — Medical Imaging Software
Hazard
Affected units
82

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model/Catalog/Code # 2042988-001
  • Installed Product ID 707509-Centricity PACS-IW-01452391
  • UDI UDI Not Required
  • System ID HCIT4250187IW
  • Installed Product ID 613493-Centricity PACS-IW-02292544
  • System ID HCIT4507688PACS
  • Model/Catalog/Code # 2049587-009
  • Installed Product ID 4276-1-Centricity PACS-IW-00558274
  • System ID PACS-IW-168
  • Model/Catalog/Code # 2049587-011
  • Installed Product ID 12830-1-Centricity PACS-IW-00558312
  • System ID PACS-IW-477
  • Installed Product ID 4352-1-Centricity PACS-IW-00558316
  • System ID PACS-IW-89
  • Model/Catalog/Code # 2049587-012
  • Installed Product ID 100858-1-Centricity PACS-IW-00558426
  • System ID PACS-IW-412
  • Installed Product ID 4294-1-Centricity PACS-IW-00558379
  • System ID PACS-IW-304
  • Installed Product ID 13039-1-Centricity PACS-IW-00558385

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 5 recalled by GE Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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