SafeOp Patient Interface Neuromonitoring Device Recalled Due to Software Issue
Alphatec Spine, Inc. is recalling the SafeOp Patient Interface due to a software issue that may cause loss of electromyography functionality during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The device is a high-risk medical device where a software failure during surgery poses a risk of harm through increased operative time and surgical plan changes, though no injuries are reported.
Plain-English summary
Alphatec Spine, Inc. is recalling the SafeOp Patient Interface (REF: AIX11240), which is part of the SafeOp 3: Neural Informatix System.
A software issue may cause the device to experience a loss or interruption of triggered electromyography (tEMG) functionality during use. This may manifest as system faults, loss of communication between the Patient Interface and the Tablet, or prompts requiring a system reboot.
This issue may result in increased operative time and changes to surgical plans. The affected units were distributed nationwide in the states of TX, MO, and IN.
The recalled product
- Product
- SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
- Manufacturer
- Alphatec Spine, Inc.
- Affected units
- 3
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 (2)
- 2005498/ DG106220
- 2005490/ DG106230
Distribution
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