StealthStation Cranial Software Depth Gauge Synchronization Failure Risk
A software anomaly in StealthStation Cranial Software causes depth gauge displays to lose synchronization during cranial biopsy procedures, risking inaccurate surgical guidance and tissue injury.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which mandates a minimum severity of Severe (4). Although the defect involves surgical navigation during brain biopsies with risk of tissue injury, no deaths or reported injuries are documented in the source, placing this within the Severe category.
Plain-English summary
StealthStation Cranial Software, Models 9735585, 9735586 (kit), and 9735587 (kit), is subject to a Class I recall due to software anomalies occurring during non-axial and some axial exams. The anomalies cause the depth gauge graphic display to lose synchronization with other navigational information, resulting in inaccurate depth readings.
During cranial biopsy procedures, when the depth gauge becomes desynchronized from other navigation data, surgeons may receive inaccurate depth information. This can result in prolonged or additional surgical procedures and potential tissue injury.
Approximately 746 units have been distributed worldwide, including throughout the United States and to over 35 international countries. Medtronic Navigation, Inc., is the manufacturer of this navigation software used with StealthStation S7/i7 systems.
The recalled product
- Product
- StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
- Manufacturer
- Medtronic Navigation, Inc.
- Hazard
- software-anomaly
- display-synchronization-failure
- inaccurate-depth-readings
- tissue-injury
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Model/UDI-DI
- Software Version: 9735585/00763000631635
- 9735586/00763000631765
- 9735587/00763000631826
- 3.1.4
Distribution
Distributed nationwide across the United States.
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