Z-2313-2016Class II

Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a...

Name: Z-2313-2016 Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a...
Creator: Medtronic Navigation, Inc.
Published: 2016-07-18
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2016-07-18 / Terminated / root cause: software

FDA source

Medtronic Navigation, Inc. began a recall of Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The... on 2016-07-18. FDA classified it as Class II and gives the reason as "Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2313-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-18
Posted: 2016-08-02
Terminated: 2016-12-01
Recalling firm: Medtronic Navigation, Inc
Product: Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
Root cause tag: software
FDA root cause: Software design
Action: Medtronic sent an Urgent Medical Device Safety Alert to all affected customers on August 20, 2016. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached confirmation form and return to [email protected] or fax it to Medtronic Technical Service at 651-367-7075. For questions contact Neurologica Technical Support at 1-888-564-8561 (US/Canada) or +1-978-564-8561 (International) or email [email protected]
Quantity in commerce: 27 in total
Distribution: Worldwide Distribution - US Nationwide in the state of: NY, AZ, AR, NC, CA, OH, MI, IN, MA, TX, OH, OR, CO, MO, UT, IL. and the countries of: India, Australia, and Russian Federation.
Product codes and lots: Model Number 9733763. All lot numbers manufactured by Medtronic Navigation are affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2313-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2313-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-02
Z-2314-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-02
Z-2315-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-02
Z-2316-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-02
Z-2317-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-02
Z-2318-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-02
Z-2319-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-02

Product code HAW

K050438Class IIStealthstation System UpdateMedtronic Surgical Navigation Technologies / cleared 2005-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)