The Recall Desk
HighFDA (Devices)·Z-1783-2014·Announced 2014-06-18

Philips IntellVue Info Center Patient Monitor Recall for Reboot Loop

Philips is recalling IntellVue Info Center monitors because a software defect causes reboot loops that interrupt patient monitoring.

What this means for you

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 recall involves a high-risk medical device where a defect can interrupt patient monitoring, representing a risk of harm even though specific injuries are not reported in the source text.

Plain-English summary

Philips Healthcare Inc. is recalling 899 units of the IntellVue Info Center iX and related patient physiological monitors. The affected devices include the IntellVue Info Center iX (866023), PIIC iX Upgrade (866024), IntellVue Server iX Upgrade (866026), and PIIC Classic Upgrade (866117). These units were distributed nationwide in the United States and in Canada.

The recall is due to a software defect in version A.01. If a customer creates customized trend scales and the device or primary server reboots, the system enters a reboot loop. This issue impacts patients monitored on the affected device; if the primary server reboots, all patients across all connected iX devices are impacted.

Healthcare facilities should contact Philips Healthcare Inc. for instructions on how to resolve the issue. The source text does not specify a specific action for consumers, as these are professional medical devices.

The recalled product

Product
Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor.
Affected units
899

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 (1)

  • All iX versions with A.01 software

Distribution

Distributed nationwide across the United States.