Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 8660...

FDA Device Recall #Z-1783-2014 — Class II — March 5, 2013

Recall Summary

Recall Number Z-1783-2014
Classification Class II — Moderate risk
Date Initiated March 5, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Philips Healthcare Inc.
Location Andover, MA
Product Type Devices
Quantity 899

Product Description

Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor.

Reason for Recall

If a customer creates customized trend scales in the trend review tile and the iX or primary server reboots for any reason, the iX(s) will enter a reboot loop. If one iX reboots, the issue will impact only those patients monitored on that device. If the primary server reboots, all patients across all iX devices will be impacted.

Distribution Pattern

Worldwide Distribution: US (nationwide) and country of: Canada.

Lot / Code Information

All iX versions with A.01 software

Other Recalls from Philips Healthcare Inc.

Recall # Classification Product Date
Z-2059-2013 Class II Philips Easy Upgrade DR, Code No: 712086 Thi... Aug 8, 2013
Z-1780-2013 Class II Radiohead Access Point 1.4 GHz Radiohead Access... Jul 8, 2013
Z-1797-2013 Class II Philips HeartStart MRx Monitor/Defibrillator, ... Jun 19, 2013
Z-1964-2013 Class II Philips Healthcare MobileDiagnostwDR system. M... Jun 11, 2013
Z-1189-2013 Class II HeartStart MRx Monitor/Defribillator; Product C... Apr 8, 2013

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.