The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1486-2025·Announced 2025-04-09

GE Healthcare Cardiology CA1000 Security Vulnerability Could Allow Patient Data Access

GE Healthcare Centricity Cardiology CA1000 has a security vulnerability where service login credentials can be identified, potentially allowing unauthorized access to patient data.

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 an FDA Class II recall involving a security vulnerability with potential for patient data access and manipulation. While no illnesses or unauthorized access incidents have been reported, the vulnerability presents a significant risk of harm consistent with risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Healthcare Centricity Cardiology CA1000 (CA1000) is being recalled due to a security vulnerability. The system's service login credentials can be identified by malicious actors, which could allow unauthorized access to the system and potential manipulation of patient data.

A total of 633 units of the CA1000 have been distributed worldwide across healthcare facilities. This includes various model numbers and system configurations.

Healthcare organizations with affected CA1000 systems should contact GE Healthcare for information about addressing this vulnerability to ensure continued patient data security and system integrity.

The recalled product

Product
GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571-010; 9) 2109571-011; 10) 2109571-012; 11) MANLEGACY111; 12)…
Manufacturer
GE Healthcare
Category
Medical Device — Cardiology / Diagnostic Software
Hazard
Affected units
633

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 # 2033901-001
  • Installed Product ID 14335625-Centricity CA1000-19675863
  • UDI UDI Not Required
  • System ID HCIT4082079CA1000
  • Model/Catalog/Code # 2038437-001
  • Installed Product ID 11558-1-Centricity CA1000-00099550
  • System ID 520855CA1SW1
  • Installed Product ID 103987-1-Centricity CA1000-00102841
  • System ID 928537CA1SW1
  • Installed Product ID 9990-1-Centricity CA1000-00101135
  • UDI UDI not required
  • System ID 661327CWS01
  • Installed Product ID 10318-1-Centricity CA1000-00105877
  • System ID 818397CA1SW1
  • Installed Product ID 10994-1-Centricity CA1000-00102387
  • UDI UDI Not required
  • System ID 909464CA1SW1
  • Installed Product ID 102131-1-Centricity CA1000-00105886
  • System ID 818409CA1SW1
  • Installed Product ID 4161-1-Centricity CA1000-00105894

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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