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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

GE Healthcare GmbH: ViewPoint Imaging Systems Recalled Due to Data Security Vulnerability

Agency Publication Date: September 13, 2024
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Summary

GE Healthcare is recalling approximately 577 units of ViewPoint and ViewPoint 6 radiological imaging processing systems because they may contain a software vulnerability in a component called Mirth Connect (versions prior to 4.4.1). This flaw involves the improper handling of data, which could be exploited by unauthorized individuals. The affected systems were distributed nationwide across 49 U.S. states and the District of Columbia.

Risk

A malicious actor could exploit this vulnerability to gain unauthorized access to the system, potentially allowing them to view or manipulate sensitive patient data. While no specific patient injuries or data breaches have been reported in this notice, the vulnerability poses a risk to patient privacy and data integrity.

What You Should Do

  1. Check your system identification and model numbers to see if your unit is affected. Impacted models include ViewPoint (System IDs QB7A TA99, N26D M0B7, Q1K1 FFQW) and ViewPoint 6 (Models H47581RJ, H47591MA, H47591MT, H47591PE, H47591PR, H47591RA, H47591SD, and H47591YA).
  2. Verify your System ID against the extensive list of hundreds of specific identifiers, such as 4AD8 4XH3, ND1G 9XAQ, A9PQ QW8P, and many others listed in the official recall notice.
  3. Immediately contact GE Healthcare or your medical facility's IT/security department to determine if the Mirth Connect software on your ViewPoint system has been updated to version 4.4.1 or later.
  4. Follow any specific technical instructions provided by GE Healthcare in the notification letter sent on August 8, 2024, regarding software patches or configuration changes.
  5. Contact GE Healthcare GmbH directly at their Munich headquarters or through your local GE Healthcare service representative for technical support and to confirm your system is secured.
  6. For further information or questions regarding this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Software vulnerability mitigation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: ViewPoint Imaging Processing System
Lot Numbers:
System ID: QB7A TA99
System ID: N26D M0B7
System ID: Q1K1 FFQW
Product: ViewPoint 6 Imaging Processing System
Model / REF:
H47581RJ
H47591MA
H47591MT
H47591PE
H47591PR
H47591RA
H47591SD
H47591YA
Lot Numbers:
4AD8 4XH3
JC82 KQTA
JZNQ HCW6
8X0C HWWG
NURM T75T
7R98 NQWY
AS41 ZJKE
ZU21 YYU8
E09H GGMN
DZMC NUA6
CYPQ ARE7
HJDP BKTB
TMQA Y5KK
UDI/DI (01)00840682103640(10)SP1
UDI/DI (01)00840682103640(10)SP2
UDI/DI (01)00840682119627(10)ViewPoint6ver6.8SP1
UDI/DI (01)00840682124454(10)ViewPoint6ver6.9SP1
UDI/DI (01)00840682140744(10)ViewPoint6ver6.10SP1
UDI/DI (01)00840682140744(10)ViewPoint6ver6.10SP2
UDI/DI (01)00840682145718(10)ViewPoint6ver6.11SP0
UDI/DI (01)00840682145718(10)ViewPoint6ver6.11SP1
UDI/DI (01)00840682145718(10)ViewPoint6ver6.11SP2
UDI/DI (01)00840682171953(10)ViewPoint6ver6.12SP0
UDI/DI (01)00840682171953(10)ViewPoint6ver6.12SP1(11)210400
UDI/DI (01)00840682171953(10)ViewPoint6ver6.12SP2(11)211000
UDI/DI (01)00840682171953(10)ViewPoint6ver6.12SP3(11)220900
UDI/DI (01)00195278517340(10)ViewPoint6.14.0.0(11)230200
UDI/DI (01)00195278517340(10)ViewPoint6.14.1.0(11)230700
UDI/DI (01)00195278517340(10)ViewPoint6.14.2.0(11)230900

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95167
Status: Active
Manufacturer: GE Healthcare GmbH
Sold By: GE Healthcare
Manufactured In: Germany
Units Affected: 2 products (3 units; 574 units)
Distributed To: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.