Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 30, 2015
Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and a cart labelled SYN-0025, Operator Cart. A planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures. It can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified.
Out of tolerance for radio frequency emissions. At the 150-1000MHz frequency, the testing indicated the BrightMatter Navigation system was up to 20dB uV/meter higher than the appl…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Synaptive Medical, Inc. recalled Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. Th… - a moderate-severity action.
Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. Th… was recalled by Synaptive Medical, Inc. in December 30, 2015. Reason: Out of tolerance for radio frequency emissions. At the 150-1000MHz frequency, the testing indicated the Brigh…. Check the official notice for the remedy. Verify recall #Z-0480-2016 with the FDA Devices before acting.
The recall
Synaptive Medical, Inc. issued this moderate-severity FDA Devices recall-Out of tolerance for radio frequency emissions. At the 150-1000MHz frequency, the testing indicated the Brigh….
- Moderate
- severity level
- 8 units
- affected scope
- Class II
- classification
- December 30, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0480-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0480-2016) was formally reported on December 30, 2015, with the manufacturer initiating the action on December 4, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Synaptive Medical, Inc. is listed as the recalling firm, operating out of Toronto, N/A. Federal records list the affected scope as 8.
The documented reason for this recall is: Out of tolerance for radio frequency emissions. At the 150-1000MHz frequency, the testing indicated the BrightMatter Navigation system was up to 20dB uV/meter higher than the applicable IEC 60601-1-2:2007 (Ed3.0) standa… Distribution data in the federal record shows the product reached: US: FL, WI, IL, LA, WA.. 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
8
Related Recalls
6
3 from same agency
Product description
Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and a cart labelled SYN-0025, Operator Cart. A planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures. It can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified.
Reason for recall
Out of tolerance for radio frequency emissions. At the 150-1000MHz frequency, the testing indicated the BrightMatter Navigation system was up to 20dB uV/meter higher than the applicable IEC 60601-1-2:2007 (Ed3.0) standard specification.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0480-2016 |
| Date reported | December 30, 2015 |
| Date initiated | December 4, 2015 |
| Recalling firm | Synaptive Medical, Inc. |
| Firm location | Toronto, N/A |
| Affected scope | 8 |
| Distribution | US: FL, WI, IL, LA, WA. |
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-0480-2016) 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? ▼
Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and a cart labelled SYN-0025, Operator Cart. A planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures. It can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified.. Recalled by Synaptive Medical, Inc.. Units affected: 8.
Why was this product recalled? ▼
Out of tolerance for radio frequency emissions. At the 150-1000MHz frequency, the testing indicated the BrightMatter Navigation system was up to 20dB uV/meter higher than the applicable IEC 60601-1-2:2007 (Ed3.0) standard specification.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 30, 2015. Severity: Moderate. Recall number: Z-0480-2016.
Where was the recalled product distributed? ▼
Distribution: US: FL, WI, IL, LA, WA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0480-2016) 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 30, 2015. 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.