🔍 RecallPedia

Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

Class I - Dangerous
🏥 Medical Devices Recalled: December 10, 2020 GE Healthcare Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    Discovery NM 630 (Model Number H3101RH), Serial numbers: 63GY50110, 63GY50119, 63GY50116, 63GZ50141, 63GY50120, 63GY50108, 63GY50121, 63GZ50142, 63GY50112, 63GZ50139, 63GY50107, 63GZ50138 NM 830 (Model Number H3910AC), Serial Numbers: 830Z60199, 830Z60182, 830Z60183, 830Z60192, 830Y60089, 830Y60105, 830Y60079, 830Z60207, 830Y60092, 830Y60102, 830Y60081, 830Z60200, 830Y60106, 830Z60201, 83EZ88001, 830Y60111, 830Y60094, 830Z60211, 830Y60101, 830Z60210, 830Y60118, 830Z60195, 830Z60194, 830Z60198, 830Z60181, 830Z60202, 830Y60097, 830Z60196, 830Z60180, 830Y60078, 830Y60115, 830Y60114, 830Y60108, 830Y60100, 830Y60087, 830Y60084, 830Z60188, 830Z60206, 830Y60112, 830Y60082, 830Y60093, 830Z60191, 830Y60107, 830Y60080, 830Z60190, 830Y60103, 830Z60193, 830Y60095, 830Y60119, 830Z60209, 830Z60205, 830Y60073, 830Y60120, 830Y60083, 830Y60116, 830Z60203, 830Y60085, 830Y60077, 830Z60184, 830Y60086, 830Z60187, 830Y60113, 830Z60208, 830Y60110, 830Z60204, 830Y60072, 830Z60179, 830Z60186 830 NM Cyber Defense (Model Number H3910AG), Serial Numbers: 830Z60185
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
GE Healthcare, LLC
Reason for Recall:
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

Product Codes/Lot Numbers:

Discovery NM 630 (Model Number H3101RH), Serial numbers: 63GY50110, 63GY50119, 63GY50116, 63GZ50141, 63GY50120, 63GY50108, 63GY50121, 63GZ50142, 63GY50112, 63GZ50139, 63GY50107, 63GZ50138 NM 830 (Model Number H3910AC), Serial Numbers: 830Z60199, 830Z60182, 830Z60183, 830Z60192, 830Y60089, 830Y60105, 830Y60079, 830Z60207, 830Y60092, 830Y60102, 830Y60081, 830Z60200, 830Y60106, 830Z60201, 83EZ88001, 830Y60111, 830Y60094, 830Z60211, 830Y60101, 830Z60210, 830Y60118, 830Z60195, 830Z60194, 830Z60198, 830Z60181, 830Z60202, 830Y60097, 830Z60196, 830Z60180, 830Y60078, 830Y60115, 830Y60114, 830Y60108, 830Y60100, 830Y60087, 830Y60084, 830Z60188, 830Z60206, 830Y60112, 830Y60082, 830Y60093, 830Z60191, 830Y60107, 830Y60080, 830Z60190, 830Y60103, 830Z60193, 830Y60095, 830Y60119, 830Z60209, 830Z60205, 830Y60073, 830Y60120, 830Y60083, 830Y60116, 830Z60203, 830Y60085, 830Y60077, 830Z60184, 830Y60086, 830Z60187, 830Y60113, 830Z60208, 830Y60110, 830Z60204, 830Y60072, 830Z60179, 830Z60186 830 NM Cyber Defense (Model Number H3910AG), Serial Numbers: 830Z60185

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0856-2021

Related Recalls

GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 2066908-136; 4) 2104867-045.

GE Healthcare

Class I - Dangerous

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.

Feb 19, 2025 Infusion Pumps View Details →

GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; 4) 2038437-011; 5) 2038437-012; 6) 2038437-013; 7) 2038437-014; 8) 2038437-0XX; 9) 2098071-004; 10) 2109571-002; 11) 2109571-006; 12) 2109571-010; 13) 2109594-009; 14) 2109594-011; 15) K2090PS; 16) K2090PTED; 17) MANLEGACY114; 18) MANLEGACY64.

GE Healthcare

Class I - Dangerous

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.

Feb 19, 2025 Other Medical Devices View Details →

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.

GE Healthcare

Class I - Dangerous

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.

Feb 19, 2025 Other Medical Devices View Details →