Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 14, 2016
Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and maintain the system. DICOM devices (e.g. modalities, workstations) communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction other systems have with the Centricity Enterprise Archive. Centricity Enterprise Archive is not intended for use in patient vicinity. The intended u
There is a potential for data loss associated with empty path names resulting from HL-7 updates when the cache disk is almost full. In an unlikely event that the cache disk is alm…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ge Healthcare It recalled Centricity Enterprise Archive is a software product for receiving, archiving and sending … - a moderate-severity action.
Centricity Enterprise Archive is a software product for receiving, archiving and sending … was recalled by Ge Healthcare It in September 14, 2016. Reason: There is a potential for data loss associated with empty path names resulting from HL-7 updates when the cach…. Check the official notice for the remedy. Verify recall #Z-2739-2016 with the FDA Devices before acting.
The recall
Ge Healthcare It issued this moderate-severity FDA Devices recall-There is a potential for data loss associated with empty path names resulting from HL-7 updates when the cach….
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- September 14, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2739-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2739-2016) was formally reported on September 14, 2016, with the manufacturer initiating the action on November 16, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Ge Healthcare It is listed as the recalling firm, operating out of Barrington, IL. Federal records list the affected scope as 1,379 units.
The documented reason for this recall is: There is a potential for data loss associated with empty path names resulting from HL-7 updates when the cache disk is almost full. In an unlikely event that the cache disk is almost full (<100MB) and HL-7 update events… Distribution data in the federal record shows the product reached: Nationwide Distribution. 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
1,379 units
Related Recalls
6
3 from same agency
Product description
Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and maintain the system. DICOM devices (e.g. modalities, workstations) communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction other systems have with the Centricity Enterprise Archive. Centricity Enterprise Archive is not intended for use in patient vicinity. The intended users for Centricity Enterprise Users service personnel and System administrators, and non clinical users. As of V4.0 XDS enabled systems can communicate with the archive using the XDS and XDS-I profiles (published by IHE).
Reason for recall
There is a potential for data loss associated with empty path names resulting from HL-7 updates when the cache disk is almost full. In an unlikely event that the cache disk is almost full (<100MB) and HL-7 update events are received, the update action fails and an empty path name is written to the EA database. As a result the instance is not deleted from the storage device but no longer referenced. When trying to retrieve the instance an error is returned.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2739-2016 |
| Date reported | September 14, 2016 |
| Date initiated | November 16, 2012 |
| Recalling firm | Ge Healthcare It |
| Firm location | Barrington, IL |
| Affected scope | 1,379 units |
| Distribution | Nationwide Distribution |
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-2739-2016) 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? ▼
Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and maintain the system. DICOM devices (e.g. modalities, workstations) communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction other systems have with the Centricity Enterprise Archive. Centricity Enterprise Archive is not intended for use in patient vicinity. The intended users for Centricity Enterprise Users service personnel and System administrators, and non clinical users. As of V4.0 XDS enabled systems can communicate with the archive using the XDS and XDS-I profiles (published by IHE).. Recalled by Ge Healthcare It. Units affected: 1,379 units.
Why was this product recalled? ▼
There is a potential for data loss associated with empty path names resulting from HL-7 updates when the cache disk is almost full. In an unlikely event that the cache disk is almost full (<100MB) and HL-7 update events are received, the update action fails and an empty path name is written to the EA database. As a result the instance is not deleted from the storage device but no longer referenced. When trying to retrieve the instance an error is returned.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 14, 2016. Severity: Moderate. Recall number: Z-2739-2016.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2739-2016) 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 14, 2016. 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.