# Major Recall Alert: Stryker Issues Recall for CranialMask Tracker Due to Software Error
Stryker has announced an urgent recall of its **CranialMask Tracker (p/n 6000-390-000)** after identifying a crucial issue with the product’s Cranial Guidance Software. During surgery, the software may generate an unexpected error message: *"Instrument 'Face Mask (6001385000000) is not valid for this application"* when the CranialMask Tracker is activated. This software malfunction poses potential risks during surgical procedures, making it essential for medical professionals and facilities to take immediate action.
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## Why This Recall is Important
Any issue affecting medical devices used in surgery is a cause for serious concern. The CranialMask Tracker plays a critical role in neurosurgical procedures, and malfunctions like these can disrupt operations and potentially compromise patient safety.
The error message occurs when activating the CranialMask Tracker, leading to a failure in proper guidance by the system. This defect could result in surgical delays, misguidance, or reliance on alternative tools, all of which may impact patient care outcomes. Recognizing the severity of this problem, Stryker has taken action to recall the affected systems, emphasizing the company’s commitment to patient safety and high-quality performance.
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## Details of the Recall
Here are the key details you need to know about the CranialMask Tracker recall:
- **Category**: Medical Device
- **Brand Involved**: CranialMask Tracker
- **Product Name**: CranialMask Tracker (p/n 6000-390-000)
- **Recall Reason**: The Cranial Guidance Software may generate the error message: *"Instrument 'Face Mask (6001385000000) is not valid for this application"* when the device is activated during surgery. This issue could disrupt the surgical process and pose risks to patient safety.
- **Date Announced**: Noted as 30746 (specific clarification may be needed for exact publication date).
- **Safety Advisory**: Healthcare providers using this equipment should stop using the affected device immediately and consult Stryker for further instructions.
Stryker’s priority remains addressing any software-related defects promptly to restore confidence in their cutting-edge surgical solutions.
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## What You Should Do
As a healthcare provider or hospital administrator:
- **Stop Using the Device**: Cease operations involving the affected CranialMask Tracker immediately to ensure patient safety.
- **Contact Stryker**: Reach out to Stryker for further details, assistance, or to process device returns and replacements.
- **Report Adverse Effects**: Any unintended consequences or malfunctions related to this device should be reported to Health Canada or Stryker to ensure a swift response.
- For more information, visit the official recall notice at the following link: [https://recalls-rappels.canada.ca/en/alert-recall/cranialmask-tracker](https://recalls-rappels.canada.ca/en/alert-recall/cranialmask-tracker).
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## Stay Safe – Get Instant Recall Alerts
With medical device recalls like this, it’s crucial to stay informed about potential risks that could affect your practice or patients. Sign up for recall notifications or download apps designed to keep you updated immediately when recalls are issued.
### Your Safety Matters
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To learn more about this recall and ongoing updates, visit the official Canadian government recall website here: [CranialMask Tracker Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/cranialmask-tracker).