Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported September 25, 2024
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological
The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1,…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ge Healthcare GmbH recalled ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H4759… - a moderate-severity action.
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H4759… was recalled by Ge Healthcare GmbH in September 25, 2024. Reason: The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Databa…. Check the official notice for the remedy. Verify recall #Z-3146-2024 with the FDA Devices before acting.
The recall
Ge Healthcare GmbH issued this moderate-severity FDA Devices recall-The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Databa….
- Moderate
- severity level
- 574 units
- affected scope
- Class II
- classification
- September 25, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-3146-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-3146-2024) was formally reported on September 25, 2024, with the manufacturer initiating the action on August 8, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Ge Healthcare GmbH is listed as the recalling firm, operating out of Munich. Federal records list the affected scope as 574 units.
The documented reason for this recall is: The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a potential vulnerability allowing … Distribution data in the federal record shows the product reached: US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kent…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
574 units
Related Recalls
6
3 from same agency
Product description
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological
Reason for recall
The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a potential vulnerability allowing the deserialization of untrusted data (CVE-2023-43208). Mirth products may have been installed and configured with your ViewPoint / ViewPoint 6 system by GE HealthCare. This vulnerability could allow a malicious actor to access the system and potentially manipulate patient data.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-3146-2024 |
| Date reported | September 25, 2024 |
| Date initiated | August 8, 2024 |
| Recalling firm | Ge Healthcare GmbH |
| Firm location | Munich |
| Affected scope | 574 units |
| Distribution | US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mai… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-3146-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological. Recalled by Ge Healthcare GmbH. Units affected: 574 units.
Why was this product recalled? ▼
The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a potential vulnerability allowing the deserialization of untrusted data (CVE-2023-43208). Mirth products may have been installed and configured with your ViewPoint / ViewPoint 6 system by GE HealthCare. This vulnerability could allow a malicious actor to access the system and potentially manipulate patient data.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 25, 2024. Severity: Moderate. Recall number: Z-3146-2024.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution including in the states of 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-3146-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 25, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.