ModerateClass IITerminated

FDA Devices recall · Reported August 21, 2013

StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on August 21, 2013. Severity: Moderate. Recall number: Z-1956-2013.

Q: Where was the recalled product distributed?

Distribution: Worldwide 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.

Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5.4 which can be used on Medtronic Navigation StealthStation 57 and i7 systems or a…

Recall #: Z-1956-2013
Affected scope: 572
Initiated: July 15, 2013

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

Verify with FDA Devices →

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Medtronic Navigation, Inc. recalled StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structu… - a moderate-severity action.

StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structu… was recalled by Medtronic Navigation, Inc. in August 21, 2013. Reason: Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5.4 which can…. Check the official notice for the remedy. Verify recall #Z-1956-2013 with the FDA Devices before acting.

The recall

Medtronic Navigation, Inc. issued this moderate-severity FDA Devices recall-Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5.4 which can….

Moderate
severity level: 572 units
affected scope: Class II
classification: August 21, 2013
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1956-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 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

StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.

Reason for recall

Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5.4 which can be used on Medtronic Navigation StealthStation 57 and i7 systems or a Medtronic Planning Station due to the potential of discrepancy between the exam image and the displayed measurement or overlay under certain conditions of use.

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-1956-2013
Date reported	August 21, 2013
Date initiated	July 15, 2013
Recalling firm	Medtronic Navigation, Inc.
Firm location	Louisville, CO
Affected scope	572
Distribution	Worldwide Distribution.

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

Scale of Impact

572 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-1956-2013) 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? ▼

StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.. Recalled by Medtronic Navigation, Inc.. Units affected: 572.

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on August 21, 2013. Severity: Moderate. Recall number: Z-1956-2013.

Where was the recalled product distributed? ▼

Distribution: Worldwide 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

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This recall: FDA Devices, reported August 21, 2013. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026