ModerateClass IITerminated

FDA Devices recall · Reported February 4, 2015

Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally u

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on February 4, 2015. Severity: Moderate. Recall number: Z-1027-2015.

Q: Where was the recalled product distributed?

Distribution: Nationwide Distribution.

Q: 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.

In case of a system crash, images may not be written to the hard disk and this may result in inconsistencies in the database. In case of a system crash (e.g. blue screen, power ou…

Recall #: Z-1027-2015
Affected scope: 50
Initiated: January 13, 2015

Compiled from official public sources by the publisher. · Updated September 2026

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Siemens Medical Solutions USA, Inc recalled Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended … - a moderate-severity action.

Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended … was recalled by Siemens Medical Solutions USA, Inc in February 4, 2015. Reason: In case of a system crash, images may not be written to the hard disk and this may result in inconsistencies …. Check the official notice for the remedy. Verify recall #Z-1027-2015 with the FDA Devices before acting.

The recall

Siemens Medical Solutions USA, Inc issued this moderate-severity FDA Devices recall-In case of a system crash, images may not be written to the hard disk and this may result in inconsistencies ….

Moderate
severity level: 50 units
affected scope: Class II
classification: February 4, 2015
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1027-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1027-2015) was formally reported on February 4, 2015, with the manufacturer initiating the action on January 13, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Siemens Medical Solutions USA, Inc is listed as the recalling firm, operating out of Malvern, PA. Federal records list the affected scope as 50.

The documented reason for this recall is: In case of a system crash, images may not be written to the hard disk and this may result in inconsistencies in the database. In case of a system crash (e.g. blue screen, power outage) images may not be written from cac… 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, 6 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.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

Product description

Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications

Reason for recall

In case of a system crash, images may not be written to the hard disk and this may result in inconsistencies in the database. In case of a system crash (e.g. blue screen, power outage) images may not be written from cache to the hard disk and might get lost.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-1027-2015
Date reported	February 4, 2015
Date initiated	January 13, 2015
Recalling firm	Siemens Medical Solutions USA, Inc
Firm location	Malvern, PA
Affected scope	50
Distribution	Nationwide Distribution

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

50 units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1027-2015) 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? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on February 4, 2015. Severity: Moderate. Recall number: Z-1027-2015.

Where was the recalled product distributed? ▼

Distribution: Nationwide Distribution.

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.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Devices, reported February 4, 2015. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026