Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 22, 2014
eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Usage: eFilm Workstation is a software application that is used for viewing medical images. eFilm Workstation receives digital images and data from various sources (including but not limited to CT,MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Images are stored, c
There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studies open and utilizing the thumbnail panel to select multiple series from multiple s…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Merge Healthcare, Inc. recalled eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (P… - a moderate-severity action.
eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (P… was recalled by Merge Healthcare, Inc. in October 22, 2014. Reason: There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studies open and u…. Check the official notice for the remedy. Verify recall #Z-0068-2015 with the FDA Devices before acting.
The recall
Merge Healthcare, Inc. issued this moderate-severity FDA Devices recall-There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studies open and u….
- Moderate
- severity level
- 3K units
- affected scope
- Class II
- classification
- October 22, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0068-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0068-2015) was formally reported on October 22, 2014, with the manufacturer initiating the action on August 28, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Merge Healthcare, Inc. is listed as the recalling firm, operating out of Hartland, WI. Federal records list the affected scope as 2,630.
The documented reason for this recall is: There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studies open and utilizing the thumbnail panel to select multiple series from multiple studies may lead to the selection of an i… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide and the countries of : Argentina, Australia, Canada, Chile, France, Germany, Hungary, Iceland, Italy, Lithuania, Mexico, New Zealand, Romania, Russia, South Africa, Sweden, and Ye…. 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
2,630
Related Recalls
6
3 from same agency
Product description
eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Usage: eFilm Workstation is a software application that is used for viewing medical images. eFilm Workstation receives digital images and data from various sources (including but not limited to CT,MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. In addition, eFilm Workstation can be integrated with an institution s existing HIS or RIS for a fully integrated electronic patient record.
Reason for recall
There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studies open and utilizing the thumbnail panel to select multiple series from multiple studies may lead to the selection of an incorrect study.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0068-2015 |
| Date reported | October 22, 2014 |
| Date initiated | August 28, 2014 |
| Recalling firm | Merge Healthcare, Inc. |
| Firm location | Hartland, WI |
| Affected scope | 2,630 |
| Distribution | Worldwide Distribution - US Nationwide and the countries of : Argentina, Australia, Canada, Chile, France, Germany, Hungary, Iceland, Italy, Lithuania, Mexico, New Zealand, Romania, Russia, South Africa, Sweden, and Yemen. |
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-0068-2015) 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? ▼
eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Usage: eFilm Workstation is a software application that is used for viewing medical images. eFilm Workstation receives digital images and data from various sources (including but not limited to CT,MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. In addition, eFilm Workstation can be integrated with an institution s existing HIS or RIS for a fully integrated electronic patient record.. Recalled by Merge Healthcare, Inc.. Units affected: 2,630.
Why was this product recalled? ▼
There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studies open and utilizing the thumbnail panel to select multiple series from multiple studies may lead to the selection of an incorrect study.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 22, 2014. Severity: Moderate. Recall number: Z-0068-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide and the countries of : Argentina, Australia, Canada, Chile, France, Germany, Hungary, Iceland, Italy, Lithuania, Mexico, New Zealand, Romania, Russia, South Africa, Sweden, and Yemen..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0068-2015) 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 October 22, 2014. 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.