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Recalls & Safety AlertsVersion 5

FDA Publishes Class II Recall for Alphatec SafeOp Patient Interface Over Software Fault

The enforcement record covers three units distributed in Texas, Missouri and Indiana and lists the action as ongoing.

By AI ReporterUpdated Aug 7, 2026, 10:56 a.m. ET
The US Food and Drug Administration has published an enforcement report, recall number , covering the SafeOp Patient Interface, catalog reference AIX11240, part of the SafeOp 3: Neural Informatix System, made by The record lists the recall as initiated on May 13, 2026, with a report date of July 29, 2026, and gives the status as . The quantity is listed as 3, with US nationwide distribution in the states of TX, MO and IN. Identifying codes given in the record are UDI-DI 00190376517506 and system set ID/patient interface serial numbers 2007716/ DG106225, 2005498/ DG106220 and 2005490/ DG106230. The reason stated in the FDA enforcement report is that the intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; the record says this may result in increased operative time and surgical plan change. The action is classified in the same enforcement record. The FDA defines as its middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The event remains open and the enforcement record may be updated. The patient interface is hospital hardware rather than a consumer product. According to FDA 510(k) records for the SafeOp 3 system (K234092 and K252842), it is a intraoperative neuromonitoring device regulated under 21 CFR 882.1870 and cleared for US marketing through the 510(k) pathway. Those records describe a mains-powered, plastic-housed electronics box that runs from an external power pack and mounts on an IV pole, providing amplifier channels and a stimulator output. Disposable electrode harnesses, surface or subdermal needle electrodes and stimulating probes plug into it, and it passes the acquired signals (MEP, SSEP, EMG, TO4) by USB to the system's Alpha Informatix Tablet and docking station for viewing by trained healthcare professionals during spinal surgery. It is reusable capital equipment supplied to hospitals and surgical facilities; a member of the public would not buy, own or handle one. The FDA's enforcement database records no other enforcement action by this firm. That history is context only and says nothing about fault in this action.

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Revision history

  1. Version 57 Aug 2026, 14:56current

    Removed the unsupported electrical-supply figures from the device-description paragraph (the "100\u2013240 VAC supply via a 12 VDC power pack" clause), replacing them with the non-numeric statement that the unit is mains-powered and runs from an external power pack; also dropped the unsourced enclosure dimensions, weight and channel count from that sentence while keeping the point that it is IV-pole-mounted hospital capital equipment. Serial numbers now printed exactly as the fact set gives them (2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230). Added explicit attribution to the FDA enforcement report for the stated reason and the Class II classification. No other substantive changes.

  2. Version 47 Aug 2026, 06:27

    Product-background paragraph rewritten to match the cited AccessGUDID and FDA 510(k) records, removing device specifications not supported by those sources.

  3. Version 37 Aug 2026, 01:01

    Expanded the device-background paragraph with the FDA regulatory classification (21 CFR 882.1870), system components and filed physical/electrical specifications and cleared indications; removed the unsupported detail about a separate power-supply model number.

  4. Version 26 Aug 2026, 20:28

    Added the 510(k) clearance number K252842, the manufacturer's Carlsbad, California location, and the separately listed AIX11241 power supply accessory from the AccessGUDID database.

  5. Version 16 Aug 2026, 15:54

    First published.

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