ModerateClass IITerminated

FDA Devices recall · Reported December 3, 2014

Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301C X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, hi

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on December 3, 2014. Severity: Moderate. Recall number: Z-0471-2015.

Q: Where was the recalled product distributed?

Distribution: US Nationwide Distribution to CA, MA, MD.

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-0471-2015) 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.

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.

Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results may be displayed in the Function Parameters for the Entire Heart displayed as anal…

Recall #: Z-0471-2015
Affected scope: 1 unit within the U.S. only
Initiated: November 5, 2014

Compiled from official public sources by the editorial team. · Updated July 2026

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Toshiba American Medical Systems Inc recalled Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The softwar… - a moderate-severity action.

Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The softwar… was recalled by Toshiba American Medical Systems Inc in December 3, 2014. Reason: Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results may be displ…. Check the official notice for the remedy. Verify recall #Z-0471-2015 with the FDA Devices before acting.

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The recall

Toshiba American Medical Systems Inc issued this moderate-severity FDA Devices recall-Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results may be displ….

Moderate
severity level: 1 units
affected scope: Class II
classification: December 3, 2014
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0471-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-0471-2015) was formally reported on December 3, 2014, with the manufacturer initiating the action on November 5, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Toshiba American Medical Systems Inc is listed as the recalling firm, operating out of Tustin, CA. Federal records list the affected scope as 1 unit within the U.S. only.

The documented reason for this recall is: Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results may be displayed in the Function Parameters for the Entire Heart displayed as analysis results of the CFA and in a Left-Ve… Distribution data in the federal record shows the product reached: US Nationwide Distribution to CA, MA, MD. 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.

Where this recall sits in the database

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.

Severity

Moderate

Affected scope

1 unit within the U.S. only

Related Recalls

3 from same agency

Product description

Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301C X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro. The CT cardiac function analysis software is used to analyze cardiac function using data obtained by performing cardiac MPR processing for ECG-gated scan data according to the cardiac axis. Aquilion ONE is a dynamic volume CT system that supports whole-body scanning. This 320-detector row system generates 640 slices per rotation using the coneXact reconstruction algorithm. In addition, the high-speed rotation mechanism and the fast reconstruction unit of the system allow the rapid image acquisition to further improve throughput in CT examinations.

Reason for recall

Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results may be displayed in the Function Parameters for the Entire Heart displayed as analysis results of the CFA and in a Left-Ventricular Volume Curve generated based on some of those parameters.

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-0471-2015
Date reported	December 3, 2014
Date initiated	November 5, 2014
Recalling firm	Toshiba American Medical Systems Inc
Firm location	Tustin, CA
Affected scope	1 unit within the U.S. only
Distribution	US Nationwide Distribution to CA, MA, MD

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

Scale of Impact

1 unit within the U.S. only 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-0471-2015) 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 December 3, 2014. Severity: Moderate. Recall number: Z-0471-2015.

Where was the recalled product distributed? ▼

Distribution: US Nationwide Distribution to CA, MA, MD.

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-0471-2015) 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 December 3, 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.