Philips Fluoroscopy System Recall Over Hard Disk Drive Issue

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling 257 units of its Allura, Cardio Vascular-Allura Centron interventional fluoroscopic X-ray system, model number 722400. The recall affects units distributed nationwide in the United States.

The recall is being issued because unauthorized hard disk drives may be installed in the affected systems. These drives can lead to a potential loss of imaging functionality, loss of motorized movement, or loss of data during operation.

Healthcare facilities and users of the affected systems are the population potentially impacted by this recall. No injuries or illnesses have been reported in connection with this issue.

Affected customers should contact Philips Medical Systems to arrange for inspection and replacement of any unauthorized hard disk drives. Until corrective action is completed, users should be aware of the potential for imaging or movement disruptions during procedures.

The recalled product

Product

Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.

Manufacturer

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Category

Medical Device — Interventional Fluoroscopic X-Ray System

Hazard

• loss-of-function
• data-loss
• unauthorized-component

Affected units

257

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Related recalls