Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 27, 2014
Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and the study is exported before the image is upda…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips Healthcare Informatics, Inc. recalled Philips IntelliSpace PACS 4.4 image management systems performs digital image processing,… - a moderate-severity action.
Philips IntelliSpace PACS 4.4 image management systems performs digital image processing,… was recalled by Philips Healthcare Informatics, Inc. in August 27, 2014. Reason: A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed …. Check the official notice for the remedy. Verify recall #Z-2252-2014 with the FDA Devices before acting.
The recall
Philips Healthcare Informatics, Inc. issued this moderate-severity FDA Devices recall-A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed ….
- Moderate
- severity level
- 109 units
- affected scope
- Class II
- classification
- August 27, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2252-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2252-2014) was formally reported on August 27, 2014, with the manufacturer initiating the action on July 24, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Philips Healthcare Informatics, Inc. is listed as the recalling firm, operating out of Foster City, CA. Federal records list the affected scope as 109 units.
The documented reason for this recall is: A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and the study is exported before the image is updated in the PACS, the unchanged data may … Distribution data in the federal record shows the product reached: US and Australia, Belgium, Canada, Egypt, France, Germany, Netherlands, Oman, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom.. 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
109 units
Related Recalls
6
3 from same agency
Product description
Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
Reason for recall
A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and the study is exported before the image is updated in the PACS, the unchanged data may export causing the potential for diagnosis on incomplete data.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2252-2014 |
| Date reported | August 27, 2014 |
| Date initiated | July 24, 2014 |
| Recalling firm | Philips Healthcare Informatics, Inc. |
| Firm location | Foster City, CA |
| Affected scope | 109 units |
| Distribution | US and Australia, Belgium, Canada, Egypt, France, Germany, Netherlands, Oman, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom. |
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-2252-2014) 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? ▼
Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.. Recalled by Philips Healthcare Informatics, Inc.. Units affected: 109 units.
Why was this product recalled? ▼
A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and the study is exported before the image is updated in the PACS, the unchanged data may export causing the potential for diagnosis on incomplete data.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 27, 2014. Severity: Moderate. Recall number: Z-2252-2014.
Where was the recalled product distributed? ▼
Distribution: US and Australia, Belgium, Canada, Egypt, France, Germany, Netherlands, Oman, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2252-2014) 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 August 27, 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.